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.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 4 and 6 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.
5. Claim 4 recites the limitation "the other end side of the electrode units" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. Claim 2, which Claim 4 depends from, recites “at one end side of the electrode unit”, but fails to recite any ‘other end side’ of the electrode units, rendering Claim 4 indefinite. For examination purposes, Claim 4 will be interpreted as follows: “… an electrode rotation shaft unit located on another end side of the electrode units…”. Proper correction is required.
6. Claim 6 recites the limitation "the plurality of the electrode units have a plurality of electrode pairs" in lines 1-3. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether the ‘plurality of electrode pairs’ defined in Claim 6 are the same as ‘a pair of electrode units’ recited in Claim 2, or distinct from this recitation, since Claim 6 depends from Claim 2. Clarification is required.
Claim Rejections - 35 USC § 102
7. 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.
8. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sánchez Jaime U.S. 2023/0117411 (herein referred to as “Sánchez Jaime”).
9. Regarding Claim 1, Sánchez Jaime teaches an RF energy generator (Figs. 1-4; para 0107, “each applicator head may include a flexible tube 150 through which each applicator head may be connected to a non-illustrated control unit (base station). The control unit may include e.g. a pump for applying vacuum, a power supply, e.g. connection with the electrical grid, and an RF generator”) capable of controlling a penetration depth of energy (para 0007, “the penetration depth of the treatment is modified too continuously throughout a treatment”; para 0088), the RF energy generator comprising:
a. a handpiece casing unit (Fig. 1, ref num 110);
b. a plurality of electrode units (Fig. 1, ref nums 120) being located to be spaced apart from one surface of the handpiece casing unit (see Fig. 1, ref nums 120 are spaced apart from one another on ref num 110; para 0082) and transmitting RF energy to skin while being in contact with the skin (para 0032, “RF energy may be applied to the skin… delivers a dynamic RF treatment through one or more static applicator heads”; para 0037, “apply RF energy through a pair of electrodes in a first applicator head”); and
c. an electrode gap control unit controlling the penetration depth of RF energy transmitted to the skin by adjusting a gap of the plurality of the electrode units in contact with the skin (para 0088, “movement of the electrode(s) 125, 130. If a distance between the electrodes is continuously changed, a depth of treatment is also continuously changed”; Fig. 6, ref num 605; para 0110, “motor 605 to drive the electrode supports and/or the electrodes”; para 0115, “activating the drive for moving the first electrode support”).
Claim Rejections - 35 USC § 103
10. 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.
11. Claims 2, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Sánchez Jaime.
12. Regarding Claim 2, Sánchez Jaime teaches a pair of the electrode units are positioned to be relative to a contact surface in contact with the skin (Fig. 7, ref nums 710, 715), and the electrode gap control unit comprises an electrode rotation unit rotating the electrode units (Fig. 6, ref num 605; para 0110 describes how the motor, ref num 605, rotates the electrode units, ref nums 120), wherein the electrode rotation unit rotates the electrode units to adjust the gap at one end side of the electrode unit in contact with the skin (see Fig. 8, reference characters “Time 1”, “Time 2”, “Time 3” shows the difference in gap between the electrodes in contact with the skin are an end; para 0087-0088, 0123).
However, Sánchez Jaime fails to teach the pair of the electrode units are tilted relative to a contact surface.
However, in another embodiment of Sánchez Jaime, there are a plurality of casing units (Fig. 4, ref nums 110, 210, 310, 410), each having a plurality of electrode units. The plurality of electrode units between the various casing units could make up a pair of electrode units. The casing units are also rotatably attached to one another (para 0106, “fastening means 145 or connections between the various applicator heads may be formed as hinges, allowing one applicator head to rotate with respect to another”) which tilts the various electrode units (para 0105, “fastening means 145 may allow to control a separation between applicator heads 110”). This configuration allows for various configurations in order to contact the desired amount of skin and vary the space between the various electrode units (para 0104-0106). As already discussed, Sánchez Jaime teaches the spacing between the electrode units controls the penetration depth at which the energy is applied (para 0035, “as the distance between electrodes is varied due to the movement of at least the first electrode, the penetration depth of the treatment is modified too continuously throughout a treatment”), which improves the effectiveness of the treatment over the desired area of the tissue (para 0131, “continuously changing distances between the electrodes can provide homogenous and effective treatment of an area of tissue”).
13. Regarding Claim 5, Sánchez Jaime teaches the pair of electrode units are capable of being rotated at different rotation speeds (para 0124, “in other examples, one or more electrodes and/or one or more electrode supports may move at different speeds. For instance, two electrode supports 120 may move at a different rotational speed”).
14. Regarding Claim 6, Sánchez Jaime teaches the plurality of the electrode units have a plurality of electrode pairs, wherein at least one electrode pair among the plurality of the electrode pairs has a direction misaligned with the other electrode pairs, such that the plurality of the electrode pairs can form the gap different from each other when rotated (see Fig. 8, there are a plurality of electrode pairs between the plurality of electrode units, i.e., electrode pair 1, 2, and 3, such that they have a direction misaligned with the other pairs; para 0123-0124, 0128).
15. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Sánchez Jaime and in view of Jurna U.S. 2015/0126913 (herein referred to as “Jurna”).
16. Regarding Claim 3, the various embodiments of Sánchez Jaime fail to teach the pair of the electrode units are positioned to be tilted while facing each other, but are positioned to be tilted in opposite directions.
Jurna teaches electrode units of analogous art (Fig. 2B, ref nums 5 and 11; together make a single unit, and there is a left unit and right unit present in Fig. 2B), such that the pair of electrode units are positioned to be tilted while facing each other (para 0034, “the low-impedance first skin tissue portions [11] extend obliquely into the skin tissue 1 at an angle .theta. with respect to the normal n to the skin surface 3 so that the longitudinal axes A of the elongated skin tissue portions of the pair converge toward each other at an angle of convergence .alpha. in a direction from the skin surface 3 toward the treatment zone 9”). The pair of electrode units are also positioned to be tilted in opposite directions (see Fig. 2B, the left electrode unit is tilted in opposite direction as the right electrode unit). This configuration of tilting the electrode units produces the same expected result of controlling the penetration depth of the energy applied by the electrode units (para 0049, “The penetration depth of the RF heating into the skin is significantly increased. This sub-surface RF heating (FIGS. 4D-4I) allows treatment of a larger tissue volume than the conventional RF electrode-only configuration (FIGS. 4A-4C). The penetration depth and localisation are controllable by selecting the oblique angle θ, and consequently of the angle of convergence α”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sánchez Jaime to tilt the pair of electrode units to face one another, but in opposite directions, as this produces the same expected result of controlling the penetration depth of the energy.
17. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Sánchez Jaime and in view of Hellmold U.S. 2024/0416136 (herein referred to as “Hellmold”).
18. Regarding Claim 4, Sánchez Jaime teaches the electrode rotation unit comprises:
a. a rotation motor unit mounted within the handpiece casing (Fig. 6, ref num 605)
Sánchez Jaime fails to teach (b) a center gear unit rotated by receiving a rotation force of the rotation motor unit; and (c) a plurality of electrode rotation gear units being mounted on an electrode rotation shaft unit located on the other end side of the electrode units and being interlocked with the center gear unit.
Hellmold teaches an electrode arrangement of analogous art (Fig. 1, ref num 10), such that the electrode arrangement comprises an electrode unit (Fig. 1, ref num 12), a handpiece casing unit (Fig. 1, ref num 11), and an electrode rotation unit (shown in Fig. 3). The electrode rotation unit comprises a rotation motor unit within the casing (Fig. 3, ref num 30), a center gear unit rotated by receiving a rotation force of the rotation motor unit (Fig. 3, ref num 31; para 0074, “a corresponding gear wheel of the drive train 31”; para 0082, “ to transmit a rotating movement initiated by the motor 30 to the drive train 31”), and an electrode rotation gear unit (Fig. 4, ref num 37b) being mounted on an electrode rotation shaft unit (Fig. 4, ref num 38; para 0084, “ the second gearwheel arrangement 37b comprises a drive shaft 38”). The rotation shaft is located on a proximal end side of the electrode unit (see Fig. 4, ref num 38 is on proximal end of ref num 12) and the electrode rotation gear unit is interlocked with the center gear unit (para 0083; see Fig. 4, ref num 37a of ref num 31 interlocks with ref num 37b). This configuration produces the same expected result of applying energy to the skin when the electrode arrangement is in contact with the skin (para 0054). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sánchez Jaime to have the electrode rotation unit as described by Hellmold as this produces the same expected result of delivery energy to the skin.
19. Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Sánchez Jaime and in view of Schwarz U.S. 12,064,163 (herein referred to as “Schwarz”).
20. Regarding Claims 7 and 8, Sánchez Jaime teaches a wearing band unit for wearing the handpiece casing unit on a patient’s body (Fig. 7, ref num 710; para 0113, “ the attachment of one or more applicator heads 110 to the skin of the subject may be performed through at least one of: suction and one or more mechanical fasteners, e.g. straps”; para 0114, “the attachment, e.g. through straps, of an applicator head 110 to the skin is performed before putting a portion of the skin and the applicator head 110 into contact”).
Sánchez Jaime fails to teach a casing connection unit for detachably coupling the wearing band unit to the handpiece casing unit and is rotatably hinged thereto.
Schwarz teaches an energy generator of analogous art (Figs. 8a/8b) wherein the generator comprises a wearing band unit for wearing a handpiece casing on a body (Fig. 8a, ref num 817 to wear ref num 800) and a casing connection unit for detachably coupling the wearing band unit to the handpiece casing unit (Fig. 8a, ref nums 806/807/809; Col. 41, lines 29-34, “the positioning mechanism which may be fixed in a recess 803 at a first end 804 of the first side portion 801 and a recess 806 at a second end 805 of the first side portion 801. The positioning mechanism, such as a belt or strap, may be fastened or its length may be adjusted by a clip 807”). The wearing band unit is rotatably hinged to the casing connection unit (Col. 41, lines 34-35, “The clip 807 may move around the pin 808 in a clockwise or counter-clockwise direction”). This positions the electrode units for better targeting of the energy treatment (Col. 41, lines 43-51). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sánchez Jaime to include a casing connection unit to attach the wearing band to the handpiece casing unit in order to position the electrode units to the body for better targeting of the energy treatment.
21. Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Sánchez Jaime and in view of Schwarz, Deno U.S. 2021/0161399 (herein referred to as “Deno”), and Perkins U.S. 2016/0037876 (herein referred to as “Perkins”).
22. Regarding Claims 9, 10, and 11, Sánchez Jaime as modified fails to teach the casing connecting unit comprises: a first hinge body unit being positioned on one side of either of the handpiece casing unit and the wearing band unit and being provided with a protruding hinge shaft; and a second hinge body unit being positioned on the other side of either of the handpiece casing unit and the wearing band unit and being provided with a shaft insertion unit where the hinge shaft is inserted, such that the first and second body units are respectively provided on both sides of the handpiece casing unit, and the second hinge body unit is provided on the other side of the handpiece casing unit, so that the plurality of the handpiece casing units enable the first hinge body unit to be coupled to the second hinge body unit to be connected to each other, further that the first hinge body unit and the second hinge body unit are respectively provided on both sides of the handpiece casing unit, and the second hinge body unit is provided on the other side of the handpiece casing unit, so that the plurality of the handpiece casing units enable the first hinge body unit to be coupled to the second hinge body unit to be connected to each other.
Deno teaches an energy generator of analogous art (Fig. 4) comprising a casing connection unit (Fig. 4, ref num 42 having ref nums 47 and 48). The casing connection unit comprises a first hinge body and a second hinge body (para 0078, “One end of the first belt portion 47 is pivotally connected to the side surface of the body 41… One end of the second belt portion 48 is pivotally connected to a portion of the side surface of the body 41 opposite to the portion to which the first belt portion 47 is connected”), such that the first hinge body and second hinge body are on opposite sides of the handpiece casing unit (see Fig. 4; para 0078). It is understood that the wearing band unit is provided with a shaft insertion unit in which a hinge shaft is inserted (para 0072, “Each belt of the pair of belts 42 is attached at one end to the side surface of the body 41”). This aids with attaching the energy generator to the patient (para 0078). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified to have modified Sánchez Jaime to have a first and second hinge body unit to being positioned on opposing sides of the handpiece casing unit in order to secure the energy generator to the patient for energy delivery.
Perkins teaches a casing connection unit comprising a first and a second hinge body (Figs. 7A-7C; ref nums 176 and 178), wherein the first and second hinge bodies are coupled to each other to be connected to each other (see Fig. 7C; para 0159-0162). This enables the coupling of the casing connection unit to the handpiece casing unit so that the device may be attached to a patient (para 0074). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sánchez Jaime to include these different hinge body units on various sides of the casing units in order to attach the handpiece unit to the connection unit and ultimately attach the device to the patient so that it may be worn by the patient during treatment.
Conclusion
23. 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.
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, Joseph Stoklosa can be reached at 571-272-1213. 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.
/ANNIE L SHOULDERS/Examiner, Art Unit 3794