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
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.
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Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-7, 12, 14, 15-16 and 18-20 of U.S. Patent No. 12,233,288. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application and patent US 12,233,288 both claim the same method of using HIFU ultrasound for medical and cosmetic treatment of skin, especially collagen and lymphatic treatment. The current application just has broader claims. US 12,233,288 claims cover all the limitations in the current application.
Claims of current application Claims of patent US 12,233,288
21 1, 14
22-29 15-16
30 6, 20
31 6, 20
32 6, 20
33 6, 20
34 1, 14
35 1, 14
36 1, 14
37 1, 14
38 3, 12, 18, 19
39 3, 5, 12, 18, 19
40 7
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 21, 34-35 and 38-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ulric et al. (US 2010/0249669).
Addressing claim 21, Ulric discloses a method, comprising:
pressing a transducer body against the skin in a treatment area, wherein the transducer body is capable of emitting high-intensity focused ultrasound energy into the treatment area below the skin (see [0067], Figs. 4A-B and 7);
moving the transducer body across the skin in the treatment area while still pressing the transducer body against the skin (see [0067], Figs. 4A-B and 7; 4 indicate moving direction of transducer);
applying high-intensity focused ultrasound energy while the transducer body is being pressed against the skin and moved across the skin to form a pattern of treatment lines in tissue at a first depth below the surface of the skin in the treatment area (see [0067], Figs. 4A-B and 7; treatment depth below skin surface and line 4 indicate treatment direction and pattern; see especially Fig. 7).
Addressing claims 34-35 and 38-39, Ulric discloses:
Addressing claim 34, wherein the high-intensity focused ultrasound energy is applied to the tissue in the treatment area as part of a medical procedure (see abstract and claim 3).
Addressing claim 35, wherein the high-intensity focused ultrasound energy is applied to the tissue in the treatment area as part of a cosmetic treatment (see abstract).
Addressing claim 38, wherein the pattern of treatment lines is formed by applying the high-intensity focused ultrasound energy during a plurality of treatment cycles (see [0010], [0067], [0099] and Figs. 6-7; multiple cycles produce multiple treatment lines).
Addressing claim 39, wherein the movement of the transducer body across the skin is a continuous movement from a first boundary of the treatment area to an opposing boundary of the treatment area during a duration of a treatment cycle (see Fig. 7; 2 is the treatment area, line 4 is created by transducer continuous movement from one boundary to the opposite boundary).
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 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Ulric et al. (US 2010/0249669) and in view of Naldoni (US 2011/0112445).
Addressing claims 22-26, Ulric does not disclose treatment/massage lymphatic area to open for drainage. In the same field of endeavor, which is skin/tissue treatment with ultrasound to improve appearance, Naldoni discloses treatment/massage lymphatic area to open for drainage (see [0049], [0056] and claim 9, drain toxin, reduction in inflammation and liquid retention in the skin is a result of treatment/massage lymphatic area to open for drainage; Ulric discloses transducer body move across the skin in the treatment area and heat produce by HIFU which stimulate the tissue; Naldoni discloses treatment of lymphatic area therefore Ulric in view of Naldoni discloses heat produce by HIFU stimulate the lymphatic area to open node for drainage; massage the lymphatic area open the node for drainage; open the node drain the toxin is a result and not a method step; wherein the toxins accumulated in the lymphatic node over time due to the blockage caused by sagging of the muscle tissue layer in the vicinity of the lymphatic node is a patient condition and not a method step). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Ulric to treatment/massage lymphatic area to open for drainage as taught by Naldoni because this help remove waste from body (see abstract and claim 9).
Claims 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Ulric et al. (US 2010/0249669, in view of Naldoni (US 2011/0112445) and further in view of Emery et al. (US 2017/0028227).
Addressing claims 27-29, Ulric does not disclose treating muscle tissue layer. Emery discloses treating muscle tissue layer (see abstract, [0095] and [0097]; treat muscle for skin tightening, lifting and amelioration of wrinkles provide youthful position; Emery also discloses treating lymphatic node; Naldoni disclose massage lymphatic area to open node for draining waste). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Ulric to treat muscle tissue layer as taught by Emery because this help skin appearance (see abstract; lifting and amelioration of wrinkles and stretch marks, etc.).
Claims 30-33 is rejected under 35 U.S.C. 103 as being unpatentable over Ulric et al. (US 2010/0249669) and in view of Liman et al. (US 2008/0146970).
Addressing claims 30-33, Ulric does not disclose tissue of the skin to rise up ahead of the moving transducer body and fixed angle is an acute angle. This is a designer choice depend on operator treatment design and only require routine skill in the art. As see in claims 30-33, the treatment transducer could be at an acute angle to force the skin to rise up or transducer can be perpendicular to the skin. Liman explicitly discloses disclose tissue of the skin to rise up ahead of the moving transducer body and fixed angle is an acute angle (see Fig. 1; Ulric discloses fixed angle perpendicular to the skin). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Ulric to hold the transducer at a fixed acute angle relative to the surface of the skin and force the skin to rise up as taught by Litman this allowing only a small region of skin to be treated for each placement of the instrument (see [0113]).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Ulric et al. (US 2010/0249669) and in view of Choi (KR 20010017140).
Addressing claim 36, Ulric does not disclose applying pressure to the skin at one or more pressure points directly above a nerve in or near the skin treatment area during the application of the high energy focused ultrasound energy, wherein the pressure is applied to the skin at the one or more pressure points directly above a nerve using one or more fingers. In the same field of endeavor, Choi discloses applying pressure to the skin at one or more pressure points directly above a nerve in or near the skin treatment area during the application of the high energy focused ultrasound energy, wherein the pressure is applied to the skin at the one or more pressure points directly above a nerve using one or more fingers (see abstract and Fig. 1; acupressure is having fingers put pressure on the pressure point above the nerve region of the body; the jade balls 230 fingers apply pressure on the pressure points of the nerve while ultrasonic plate 220 perform massage; Ulric disclose high frequency ultrasound treatment). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Ulric to have fingers apply pressure to pressure points of the nerve during ultrasonic treatment/massaging as taught by Choi because this provides further massaging effect that improve treatment.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Ulric et al. (US 2010/0249669), in view of Choi (KR 20010017140) and further in view of Naldoni (US 2011/0112445).
Addressing claim 37, Ulric does not disclose pulling the skin in a direction toward a root of the nerve while maintaining pressure on the one or more pressure points. One ordinary skill in the massaging field knows that pulling the skin in a direction toward a root of the nerve is pulling the skin the in the spine/spinal direction. Spine/spinal is the root of the nerve. This massage is called lymphatic drainage massage. One could find this information by google search (massage by pulling skin toward spine - Search). In the same field of endeavor, Naldoni discloses lymphatic drainage massage (pulling the skin in a direction toward a root of the nerve) (see [0056]; Choi discloses massage while having fingers apply pressure to pressure points therefore Ulric in view of Choi and Naldoni discloses pulling the skin in a direction toward a root of the nerve while maintaining pressure on the one or more pressure points). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Ulric to pulling the skin in a direction toward a root of the nerve as taught by Naldoni because this help remove waste from body (see abstract and claim 9).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Ulric et al. (US 2010/0249669) and in view of Emery et al. (US 2017/0028227).
Addressing claim 40, Ulric discloses denature collagen. Denature collagen stimulate production of new collagen (see applicant’s specification). However, he does not explicitly disclose collagen growth. Emery explicitly discloses induce collagen growth (see [0104] and [0116]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Ulric to have collagen growth as taught by Emery because this improves skin appearance/cosmetic result (see [0104]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2009/0177123 (see [0035]; combine ultrasound treatment with acupressure (fingers apply pressure to pressure points at/above the nerve).
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797