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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/08/25 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 1-20 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. Limitation “wherein injection of the first compound (calcium hydroxyapatite) into the tissue region increases at least one of an absorption, a penetration, a stability, a localization, a comfort, and an efficiency of the first compound when combined with the applied ultrasound (HIFU)” is unclear. It is unclear because this is not a method step. This is a result of ultrasound treatment and injecting calcium hydroxyapatite. It is unclear what method step applicant try to claim.
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 1-2 and 5-20 are rejected under 35 U.S.C. 103 as being unpatentable over Harris (US 2009/0171266 (provided in the IDS)), in view of Perry et al. (US 2015/0064165 (provided in the IDS)) and further in view of Dobak, III (US 2016/0310444 (provided in the IDS)).
Addressing claims 1, 10 and 14, Harris discloses method comprising:
applying high intensity focused ultrasound (HIFU) to a tissue region below a skin surface (see [0031-0032]);
injecting a first compound into the tissue region (see [0041-0042]),
administering a second treatment (see Figs. 1A-F);
focus a second HIFU at a depth of 1.5 mm below the skin surface (see Figs. 1A-F and [0031-0032]; Harris discloses lysing adipose and adipose is several mm below the skin surface therefore it would have been obvious to one of ordinary skill in the art that HIFU focus depth is in the range of 1.5mm and higher).
administering to a subject in need thereof an effective amount of HIFU energy (see [0031-0032]);
administering a second treatment comprising a second HIFU energy (see Figs. 1A-F);
the second treatment comprising: focusing the second HIFU energy at a depth 1.5 mm below a skin surface (see Figs. 1A-F and [0031-0032]; Harris discloses lysing adipose and adipose is several mm below the skin surface therefore it would have been obvious to one of ordinary skill in the art that HIFU focus depth is in the range of 1.5mm and higher).
applying ultrasound to a tissue region below a skin surface (see [0031-0032]);
injecting a first compound into the tissue region treated by the ultrasound (see [0041-0042]);
administering a second treatment, comprising: focusing the second HIFU energy at a depth 1.5 mm below a skin surface (see Figs. 1A-F and [0031-0032]; Harris discloses lysing adipose and adipose is several mm below the skin surface therefore it would have been obvious to one of ordinary skill in the art that HIFU focus depth is in the range of 1.5mm and higher).
Harris does not disclose wherein the first compound comprises a dermal filler, wherein the dermal filler comprises calcium hydroxyapatite. In the same field of endeavor, Perry discloses the first compound comprises a dermal filler, wherein the dermal filler comprises calcium hydroxyapatite (see [0019-0020], [0040], [0051], [0053] and [0061]; calcium hydroxyapatite is injected subdermally into the dermis). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harris to use a dermal filler, wherein the dermal filler comprises calcium hydroxyapatite as taught by Perry because the presence of the composition/filler in the target region effectively maintains the disruption of the septae, maintains separation between tissue planes after septae have been disrupted, and/or reduces or discourages regrowth or reconnection of septae (see [0020]).
Harris does not disclose injecting a second compound into the tissue region; wherein the second compound comprises a fat-reducing compound, wherein the fat-reducing compound comprises polidocanol. In the same field of endeavor, Dobak, III discloses injecting a second compound into the tissue region; wherein the second compound comprises a fat-reducing compound, wherein the fat-reducing compound comprises polidocanol (see [0007], [0034] and [0111]; polidocanol is administer in multiple treatments into subcutaneous fat below the skin surface). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harris to inject a second compound into the tissue region; wherein the second compound comprises a fat-reducing compound, wherein the fat-reducing compound comprises polidocanol as taught by Dobak, III because this help reduction of fat cells or tissue in a greater amount (see [0111]).
Harris and other references do not disclose wherein injection of the first compound into the tissue region increases at least one of an absorption, a penetration, a stability, a localization, a comfort, and an efficiency of the first compound when combined with the applied ultrasound (HIFU). However, this is not a method step. It is a result of using ultrasound to aid delivery of agent/compound (calcium hydroxyapatite). Harris discloses using ultrasound in combination with agent and this increase efficiency of treatment (see [0041-0045]). Ultrasound is well-known to help aid delivery of drug. Wherein injection of the first compound into the tissue region increases at least one of an absorption, a penetration, a stability, a localization, a comfort, and an efficiency of the first compound when combined with the applied (HIFU) is an obvious result of using ultrasound with delivery of drug/agent/compound. Also see the prior art made of record and not relied upon is considered pertinent to applicant's disclosure in the section below.
Addressing claims 2, 9, 11, 15-18 and 20, Harris discloses:
Addressing claim 2, reapplying HIFU after the dermal filler is injected to harden the dermal filler (see [0008] and [0056]; Harris discloses repeat HIFU treatment or any other treatment; Perry explicitly discloses the compound is a dermal filler; Harris in view of Perry perform repeat treatment would result in a harden dermal filler).
Addressing claim 9, focusing the HIFU at fat tissue, wherein two or more simultaneous focused ultrasound treatments heat up portions of the fat tissue (see [0004] and [0034]).
Addressing claim 11, wherein the HIFU is administered concurrently, sequentially or separately with at least one of the group consisting of: a dermal filler and a fat-reducing compound (see [0004], [0032], [0041-0042]; adiponectin is a fat reducing compound; adiponenctin is injected at any time therefore it has to be either concurrently, sequentially or separately).
Addressing claim 15, comprising applying a cavitation-prone agent to the tissue region treated by the ultrasound (see [0009] and [0034]).
Addressing claim 16, further comprising applying an additional energy source to the tissue region treated by the ultrasound (see [0011-0013] and [0050]).
Addressing claim 17, wherein the additional energy source comprises one or more of the group consisting of: visible light, laser, radio-frequency, microwave, electromagnetic, cryogenic, electron beam, and magnetic energy (see [0011-0013] and [0050]).
Addressing claim 18, wherein said ultrasound comprises high intensity focused ultrasound (HIFU) (see [0032]).
Addressing claim 20, wherein the aesthetic ultrasound effect comprises at least one of the group consisting of: a cellulite treatment, reducing wrinkles, sagging and/or laxity of the skin, reducing fat, body sculpting, and facial sculpting (see [0045]).
Addressing claim 5, Dobak, III discloses:
Addressing claim 5, wherein the polidocanol is provided in a final concentration of 0.5% w/v (see [0021] and [0068]).
Addressing claims 6-8, 12-13 and 19, Perry discloses:
Addressing claim 6, reapplying HIFU after the dermal filler is injected, thereby modifying a viscosity of the dermal filler by the application of HIFU, and shaping the dermal filler in to a designed structure by the application of HIFU (see [0008] and [0056]; Harris discloses repeat HIFU treatment or any other treatment; Perry explicitly disclose the compound is a dermal filler; Harris in view of Perry perform repeat treatment would result modifying a viscosity of the dermal filler by the application of HIFU, and shaping the dermal filler in to a designed structure by the application of HIFU).
Addressing claim 7, dissecting at least one septa in the dermal layer with a septae dissection technology (see [0019-0020] and [0030]).
Addressing claim 8, administering the dermal filler by local injection into a dermal tissue, a subcutaneous fat tissue, or both the dermal tissue and the subcutaneous fat tissue (see [0053]).
Addressing claim 12, wherein the dermal filler comprises calcium (hydroxy)phosphate particles (see [0040] and [0049]).
Addressing claim 13, wherein the fat-reducing compound and the calcium hydroxyapatite are administered concurrently, sequentially or separately (see [0040] and [0049]).
wherein the calcium (hydroxy)phosphate particles are selected from the group consisting of: monocalcium phosphate (MCP), dicalcium phosphate (DCP), calcium dihydrogen phosphate (CDP), tricalcium phosphate (TCZ) including its α-, α'- and B-polymorphs, octacalcium phosphate (OCP), biphasic tricalcium phosphate (BCP), and hydroxyapatite (see [0040]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Harris (US 2009/0171266), in view of Perry et al. (US 2015/0064165), further in view of Dobak, III (US 2016/0310444) and Esenaliev (US 2007/0078290).
Addressing claim 3, Harris also does not disclose ultrasound frequency of 10 Mhz. In the same field of endeavor, Esenaliev discloses ultrasound frequency of 10 Mhz (see [0061], [0063-0064] and [0070]; Esenaliev also explicitly discloses ultrasound treatment focus depth in the range of 1.5 mm and higher). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harris to have ultrasound frequency of 10 Mhz as taught by Esenaliev because these are effective standard treatment range for ultrasound treatment that provide good result and avoid injure patient.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Harris (US 2009/0171266), in view of Perry et al. (US 2015/0064165), further in view of Dobak, III (US 2016/0310444) and Kasioptas et al. (US 2018/0177912).
Addressing claim 4, Harris also does not disclose wherein the calcium hydroxyapatite is provided in a final concentration of 25-31 % w/w. Kasioptas discloses calcium hydroxyapatite concentration of 25-31 % w/w (see [0021] and [0068]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harris to have calcium hydroxyapatite is provided in a final concentration of 25-31 % w/w as taught by Kasioptas because this concentration amount would effective in harden calcium phosphate (hydroxyapatite) (see Kasioptas’s paragraph [0052]).
Response to Arguments
Applicant's arguments filed 10/08/25 have been fully considered but they are not persuasive. Applicant argues the reference do not disclose “wherein injection of the first compound into the tissue region increases at least one of an absorption, a penetration, a stability, a localization, a comfort, and an efficiency of the first compound when combined with the applied HIFU”. Applicant’s argument is not persuasive because this is not a method step. Further, this is an obvious result of using ultrasound in combination of drug. Harris explicitly discloses using ultrasound with agent. Ultrasound is known to help enhance drug deliver. Ultrasound energy improve the efficiency of drug delivery and uptake by the body. Also see the prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2009/0110736 (see [0010], [0074] and [0080]; injecting calcium hydroxyapatite for each treatment and perform treatment and second treatment three to four months after the first repeat treatment) and US 2001/0031740 (see [0057], [0062], [0124-0125], [0128], [0131], [0157] and [0179]; ultrasound improve transfection efficiency; ultrasound energy increase the efficiency of cellular uptake of compound (calcium hydroxyapatite)).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HIEN NGOC NGUYEN whose telephone number is (571)270-7031. The examiner can normally be reached Monday-Thursday 8:30am-6:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HIEN N NGUYEN/
Primary Examiner
Art Unit 3793