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 .
Status of Claims
This Action is in response to the amendment filed on March 16, 2026.
As directed by the amendment: Claims 39 and 45 were amended. Claims 39-50 and 52-58 are pending and currently under consideration for patentability under 37 CFR 1.104.
Claim Interpretation
Claim 39, line 16 recites “a fluid inflow channel.” In light of the specification, this has been interpreted to mean a channel that is adapted to deliver fluid from a reservoir into the distal tip of the applicator (see the last sentence of [0114] of the Specification filed April 6, 2021).
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claim 39 is objected to because of the following informalities:
Claim 39, lines 26 recites “a fluid media” and Examiner suggests --the fluid media-- to clarify the antecedent basis because “a fluid media” has already been recited in lines 17-18.
Appropriate correction is required.
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.
Claims 39, 45-49, and 52-56 are rejected under 35 U.S.C. 103 as being unpatentable over Shadduck et al. (US 2018/0303515 A1) in view of Sanchez (WO 01/39717 A1), Ignon et al. (US 2016/0038183 A1), and Ella et al. (US 2004/0260209 A1).
Regarding claim 39, Shadduck discloses a method for treating a targeted tissue (patient’s skin 124, Fig. 1) for use with a fluid source (fluid source 145, Figs. 1-3), comprising:
providing an applicator (treatment device 100, Figs. 1-3) and a negative pressure mechanism (negative pressure source 140, Figs. 1-3) adapted for applying a negative pressure in an aspiration channel (aspiration channel 142, Fig. 2) within the applicator (100), wherein a distal tip of the applicator (applicator tip 110, Fig. 2) has a distal facing surface comprising a perimeter portion (the distal facing surface of the unlabeled rim, outside the ring of ports 148, Fig. 2; see “1. Distal Facing Surface Comprising a Perimeter Portion” in annotated Fig. A below) surrounding an aspiration portion (the portion of tip 110 including skin contact surface 122, aspiration channel 142, and aspiration opening 144, see Fig. 2; see 2, the shaded portion of annotated Fig. A below);
wherein the aspiration portion (2, Fig. A below) includes:
i) a receiving space (3, dashed box in Fig. A below, this space is adapted to receive the skin adjacent the suction opening) within the distal facing surface (receiving space 3 is within the boundary of the distal facing surface 1, see Fig. A) of the applicator, and
iv) a fluid inflow channel (flow channel 146, Figs. 2) in fluid communication with the aspiration portion (the flow channel 146 has ports 148 that are located in the concave skin contact portion 122. The ports are in fluid communication with the aspiration portion because the negative pressure source draws the treatment fluid from the fluid source, to the skin surface: “the negative pressure source suctions the skin-contact surface against the skin while at the same time drawing the treatment fluid from a source to the abraded skin surface” see lines 9-14 of [0012]) outside the receiving space (see 3 in annotated Fig. A, the channel 146 and ports 148 are outside the receiving space) such that the fluid inflow channel (146, Fig. 2) delivers a fluid media directly to the targeted tissue (the channel 146 and outlet port(s) 148 are at the distal end of the device and at the skin contact area and thus will be directly delivering the fluid media to the targeted tissue, see the first sentence of [0052]);
contacting the targeted tissue (skin) with the distal tip (110) of the applicator while maintaining the distal tip against the targeted tissue (see Fig. 1, distal tip 110 is contacted against the tissue. This contact is “maintained” at least momentarily as the skin is suctioned. It is noted that the claim language does not require the contact to be held stationary for any particular amount of time); and
applying the negative pressure and moving the distal tip (110) over the targeted tissue (the operator translates the applicator over the patient’s skin and the negative pressure source suctions the skin, see lines 9-14 of [0012]), which manipulates the targeted tissue (the applicator tip 110 is pressed against the skin as seen in Fig. 1, and translated along the skin while the tissue is suctioned);
wherein activation of the negative pressure mechanism (140) causes the negative pressure to:
i) draw a fluid media from the fluid source (145) to the targeted tissue through the fluid inflow channel (146) to hydrate the targeted tissue (“the negative pressure source suctions the skin-contact surface against the skin while at the same time drawing the treatment fluid from a source to the abraded skin surface” emphasis added, see lines 9-14 of [0012] and Fig. 2).
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Annotated Figure A (from Fig. 3 of Shadduck): The applicator has a distal facing surface comprising a perimeter portion (1), an aspiration portion (2, shaded gray, including the distal ends of the inflow channel(s) 146), and a receiving space (3, dashed lines).
Shadduck is silent regarding wherein the aspiration portion includes: ii) a plurality of spherical rolling members rotatably located within the receiving space, where a portion of each of the plurality of spherical rolling members extends distally from the distal facing surface; iii) a plurality of openings in fluid communication with the aspiration channel, each of the plurality of openings being disposed within the receiving space adjacent to a spherical rolling member of the plurality of spherical rolling members; causing rotation of the plurality of spherical rolling members against the targeted tissue; and the negative pressure drawing the fluid media from the targeted tissue into the aspiration channel through the plurality of openings and around one or more of the plurality of spherical rolling members.
Sanchez teaches a related massage suctioning device (Fig. 1, Fig. 5) with an aspiration portion (2a, see shaded portion of annotated Fig. B below) including: i) a receiving space (3a, dashed box and blackened structures in annotated Fig. B below. This space receives the ball(s) 6 and suction openings 5) within a distal facing surface (4, Fig. 5) of the applicator, ii) a plurality of spherical rolling members (ball 6, Fig. 5; note that the central ball 6 may have “more than one ball (6)” positioned in the raceway, see page 3, lines 23-24 of the English translation) rotatably located within the receiving space (configured to “rotate in all directions” see page 3, line 22 of the English translation. Furthermore, the ball(s) 6 are located in receiving space 3a as seen in Fig. B below), iii) a plurality of openings (aspiration orifices 5, 5, Fig. 5) in fluid communication with the aspiration channel (5a, see Fig. B below), each of the plurality of openings (5, 5) being disposed within the receiving space (3a, see Fig. B below) adjacent to a spherical rolling member of the plurality of spherical rolling members (each aspiration opening 5, 5, is adjacent a spherical rolling member 6, see Fig. 5). Additionally, movement of the device against the skin will cause rotation of the plurality of spherical members (they are balls configured to “rotate in all directions” see page 3, line 22 of the English translation) against the targeted tissue (the spherical rolling members are placed “in the center of the head” to reduce tension or breaks in the user’s skin during aspiration while also providing massaging effects; see page 3, lines 17-22 of the English translation), which manipulates the targeted tissue (by the ball(s) 6 providing massaging effects).
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Annotated Figure B (from Fig. 5 of Sanchez): Sanchez’s aspiration portion (2a, shaded gray) includes a receiving space (3a, dashed box with blackened structures) that has more than one ball (6) rotatably located within the receiving space (3a). The aspiration portion (2a) also includes an aspiration channel (5a).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the receiving space and aspiration portion of Shadduck to include a plurality of spherical rolling members rotatably located within the receiving space, and a plurality of openings in fluid communication with the aspiration channel, and adjacent the spherical rolling member(s) that will rotate against the targeted tissue as the device is used as taught by Sanchez so the spherical rollers can be freely rolled along the skin to provide a massage effect and reduce tension or breaks in the user’s skin during aspiration.
The modified Shadduck/Sanchez method does not specifically state wherein a portion of each of the plurality of spherical rolling members extends distally from the distal facing surface; the activation of the negative pressure mechanism causes the negative pressure to: ii) draw the fluid media from the targeted tissue into the aspiration channel through the plurality of openings and around one or more of the plurality of spherical rolling members.
Ignon teaches a related fluid delivery and suctioning device (Fig. 1 includes a fluid source cartridge 200 and a vacuum hose connection via waste conduit 180, see para. [0107]-[0108]) wherein activation of a negative pressure mechanism (vacuum source, see the first sentence of [0107]) causes negative pressure to: i) draw a fluid media from the fluid source (cartridge 200 in Fig. 1) to the targeted tissue (skin) through a fluid inflow channel to hydrate the targeted tissue (“activating a suction source draws a volume of at least one treatment media to the skin surface being treated along the at least one suction region of the tip” see lines 7-9 of [0013]; see also the last sentence of [0109]), and ii) draw the fluid media from the targeted tissue (skin) into the aspiration channel (through waste conduit 180, Fig. 1) through at least one suction opening (“exfoliated skin, spent fluids and/or other waste materials can be transported away from the tip 130 to a canister … the rate of transfer of such waste materials can depend on one or more factors, such as, for example, the setting of the vacuum or suction source, the characteristics … of the various conduits or channels through which the waste materials are conveyed…” see para. [0107]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the setting of the negative pressure mechanism of Shadduck/Sanchez to be sufficient to cause the negative pressure to i) draw the fluid media from the fluid source to the targeted tissue, and ii) draw the fluid media from the targeted tissue into the aspiration channel as taught by Ignon so exfoliated skin, spent fluids, and/or other waste materials can be suctioned away from the skin and to a waste container.
In the modified Shadduck/Sanchez/Ignon method, the step of drawing the fluid media from the targeted tissue into the aspiration channel would occur through the plurality of openings (5, 5) of Sanchez and around one or more of the plurality of spherical rolling members (the openings 5, 5, of Sanchez are on either side of the one or more balls 6 and the aspiration channel extends above the ball(s). The fluid media would be aspirated from the skin near the ball(s) 6, into the orifices 5, 5, and into the aspiration channel, thus the fluid media would transport around the ball(s) 6).
The modified Shadduck/Sanchez/Ignon method is still silent regarding a portion of each of the plurality of spherical rolling members extends distally from the distal facing surface.
Ella teaches a related tissue suctioning device for face and body treatment (see Figs. 1A-1G, Fig. 2B, title) that includes a plurality of spherical rolling members (roller 22 includes a plurality of balls 24, Fig. 1F) and at least a portion of each of the plurality of spherical rolling members extends distally (see roller 22 in Fig. 2B) from the distal facing surface (surface 20, Fig. 1A). Ella states that the roller(s) protrude from the distal facing surface (protrudes beyond “proximal end” 11 of surface 20, see Fig. 2B) “for increasing the massaging action to the portion of the body under treatment” (see Fig. 2B and lines 1-4 of [0165]). One of ordinary skill in the art would have recognized that protruding the roller(s) beyond the distal facing surface would provide this increased massaging action, while still substantially reducing the tension in the skin (see Fig. 2A in comparison to Fig. 2B, the presence of the protruding ball(s) 22 in the center of the suction opening in Fig. 2B helps distribute pressure to form two smaller skin bumps 42 rather than a large skin bump 38 in Fig. 2A).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the position of the spherical rolling members (6, Sanchez) of Shadduck/Sanchez/Ignon to have at least a portion of each of the plurality of spherical rolling members extend distally from the distal facing surface as taught by Ella because this provides an increased massaging action, while still substantially reducing the tension in the skin by creating a pair of smaller skin bumps.
Regarding claim 45, Shadduck discloses a device for treating a targeted tissue of a subject (see Figs. 1-3), the device comprising:
an applicator body (housing of 100, Fig. 1);
a negative pressure mechanism (negative pressure source 140, Figs. 1-3);
a distal tip (tip 110, Figs. 1-2) of the applicator body (100) comprising a distal facing surface having a perimeter portion (the distal facing surface of the unlabeled rim, outside the ring of ports 148, Fig. 2; see “1. Distal Facing Surface Comprising a Perimeter Portion” in annotated Fig. A above) configured for contacting the targeted tissue (skin 124, see Fig. 1 and see the first sentence of [0049]), wherein the perimeter portion surrounds an aspiration portion (the portion of tip 110 including skin contact surface 122, aspiration channel 142, and aspiration opening 144, see Fig. 2; see 2, the shaded portion of annotated Fig. A above), wherein the aspiration portion comprises a receiving space (3, dashed box in Fig. A above, this space is adapted to receive the skin adjacent the suction opening);
at least one aspiration channel (aspiration channel 142, Fig. 2) configured for applying a negative pressure from the negative pressure mechanism (140);
wherein the distal tip (110) is configured to be moved over the targeted tissue to manipulate the targeted tissue (the operator translates the applicator over the patient’s skin and the negative pressure source suctions the skin, see lines 9-14 of [0012]. This manipulates the targeted tissue because the applicator tip 110 is pressed against the skin as seen in Fig. 1, and translated along the skin while the tissue is suctioned); and
wherein activation of the negative pressure mechanism (140) causes the negative pressure to:
i) draw a fluid media from a fluid source (fluid source 145, Figs. 1-3) to the targeted tissue (“the negative pressure source suctions the skin-contact surface against the skin while at the same time drawing the treatment fluid from a source to the abraded skin surface” emphasis added, see lines 9-14 of [0012] and Fig. 2) through an outlet (outlet port(s) 148 of inflow channel 146, Figs. 2-3) in the aspiration portion (outlet ports 148 are part of the aspiration portion, see 2, Fig. A above) outside the receiving space (outlet ports 148 are outside the dashed line area of annotated Fig. A, see also Figs. 1-3) when contacting the targeted tissue such that the outlet (148) delivers the fluid media directly to the targeted tissue (the channel(s) 146 and outlet port(s) 148 are at the distal end of the device and at the skin contact area and thus will be directly delivering the fluid media to the targeted tissue, see the first sentence of [0052]).
Shadduck is silent regarding a plurality of spherical rolling members rotatably located within the receiving space, where a portion of each of the plurality of spherical rolling members extends distally from the distal facing surface; a plurality of openings in fluid communication with the at least one aspiration channel, each of the plurality of openings being disposed within the receiving space adjacent to a spherical rolling member of the plurality of spherical rolling members, wherein the distal tip is configured to be moved over the targeted tissue to cause rotation of the plurality of spherical rolling members against the targeted tissue to manipulate the tissue; and the negative pressure drawing the fluid media from the targeted tissue into the at least one aspiration channel through the plurality of openings and around the plurality of spherical rolling members.
Sanchez teaches a related massage suctioning device (Fig. 1, Fig. 5) with an aspiration portion (2a, see shaded portion of annotated Fig. B above) comprising a receiving space (3a, dashed box and blackened structures in annotated Fig. B above. This space receives the ball(s) 6 and suction openings 5); a plurality of spherical rolling members (ball 6, Fig. 5; note that the central ball 6 may have “more than one ball (6)” positioned in the raceway, see page 3, lines 23-24 of the English translation) rotatably located within the receiving space (configured to “rotate in all directions” see page 3, line 22 of the English translation. Furthermore, the ball(s) 6 are located in receiving space 3a as seen in Fig. B above); a plurality of openings (aspiration orifices 5, 5, Fig. 5) in fluid communication with the at least one aspiration channel (5a, see Fig. B above), each of the plurality of openings (5, 5) being disposed within the receiving space (3a, see Fig. B above) adjacent to a spherical rolling member of the plurality of spherical rolling members (each aspiration opening 5, 5, is adjacent a spherical rolling member 6, see Fig. 5). Additionally, movement of the distal tip over the targeted tissue will cause rotation of the plurality of spherical members (they are balls configured to “rotate in all directions” see page 3, line 22 of the English translation) against the targeted tissue (the spherical rolling members are placed “in the center of the head” to reduce tension or breaks in the user’s skin during aspiration while also providing massaging effects; see page 3, lines 17-22 of the English translation), which manipulates the targeted tissue (by the ball(s) 6 providing massaging effects).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the receiving space and aspiration portion of Shadduck to include a plurality of spherical rolling members rotatably located within the receiving space, and a plurality of openings in fluid communication with the aspiration channel, and adjacent the spherical rolling member(s) that will rotate against the targeted tissue as the device is used as taught by Sanchez so the spherical rollers can be freely rolled along the skin to provide a massage effect and reduce tension or breaks in the user’s skin during aspiration.
The modified Shadduck/Sanchez device does not specifically state wherein a portion of each of the plurality of spherical rolling members extends distally from the distal facing surface; the activation of the negative pressure mechanism causes the negative pressure to: ii) draw the fluid media from the targeted tissue into the at least one aspiration channel through the plurality of openings and around the plurality of spherical rolling members.
Ignon teaches a related fluid delivery and suctioning device (Fig. 1 includes a fluid source cartridge 200 and a vacuum hose connection via waste conduit 180, see para. [0107]-[0108]) wherein activation of a negative pressure mechanism (vacuum source, see the first sentence of [0107]) causes negative pressure to: i) draw a fluid media from the fluid source (cartridge 200 in Fig. 1) to the targeted tissue (skin) through a fluid inflow channel to hydrate the targeted tissue (“activating a suction source draws a volume of at least one treatment media to the skin surface being treated along the at least one suction region of the tip” see lines 7-9 of [0013]; see also the last sentence of [0109]), and ii) draw the fluid media from the targeted tissue (skin) into the at least one aspiration channel (through waste conduit 180, Fig. 1) through at least one suction opening (“exfoliated skin, spent fluids and/or other waste materials can be transported away from the tip 130 to a canister … the rate of transfer of such waste materials can depend on one or more factors, such as, for example, the setting of the vacuum or suction source, the characteristics … of the various conduits or channels through which the waste materials are conveyed…” see para. [0107]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the setting of the negative pressure mechanism of Shadduck/Sanchez to be sufficient to cause the negative pressure to i) draw the fluid media from the fluid source to the targeted tissue, and ii) draw the fluid media from the targeted tissue into the aspiration channel as taught by Ignon so exfoliated skin, spent fluids, and/or other waste materials can be suctioned away from the skin and to a waste container.
In the modified Shadduck/Sanchez/Ignon device, the function of drawing the fluid media from the targeted tissue into the aspiration channel would occur through the plurality of openings (5, 5) of Sanchez and around one the plurality of spherical rolling members (the openings 5, 5, of Sanchez are on either side of the one or more balls 6 and the aspiration channel extends above the ball(s). The fluid media would be aspirated from the skin near the ball(s) 6, into the orifices 5, 5, and into the aspiration channel, thus the fluid media would transport around the ball(s) 6).
The modified Shadduck/Sanchez/Ignon device is still silent regarding a portion of each of the plurality of spherical rolling members extends distally from the distal facing surface.
Ella teaches a related tissue suctioning device for face and body treatment (see Figs. 1A-1G, Fig. 2B, title) that includes a plurality of spherical rolling members (roller 22 includes a plurality of balls 24, Fig. 1F) and at least a portion of each of the plurality of spherical rolling members extends distally (see roller 22 in Fig. 2B) from the distal facing surface (surface 20, Fig. 1A). Ella states that the roller(s) protrude from the distal facing surface (protrudes beyond “proximal end” 11 of surface 20, see Fig. 2B) “for increasing the massaging action to the portion of the body under treatment” (see Fig. 2B and lines 1-4 of [0165]). One of ordinary skill in the art would have recognized that protruding the roller(s) beyond the distal facing surface would provide this increased massaging action, while still substantially reducing the tension in the skin (see Fig. 2A in comparison to Fig. 2B, the presence of the protruding ball(s) 22 in the center of the suction opening in Fig. 2B helps distribute pressure to form two smaller skin bumps 42 rather than a large skin bump 38 in Fig. 2A).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the position of the spherical rolling members (6, Sanchez) of Shadduck/Sanchez/Ignon to have at least a portion of each of the plurality of spherical rolling members extend distally from the distal facing surface as taught by Ella because this provides an increased massaging action, while still substantially reducing the tension in the skin by creating a pair of smaller skin bumps.
Regarding claim 46, the modified Shadduck/Sanchez/Ignon/Ella device as currently combined is silent regarding wherein the perimeter portion comprises a lubricious material.
However, Shadduck additionally teaches an embodiment in which the applicator tip (610, Fig. 16) may include a skin interface of a lubricious molded silicone or similar elastomer (see the second sentence of [0085]). This would provide an expected result of allowing the skin interface to move across the skin relatively easier, for less aggressive dermabrasion (see lines 10-15 of [0052]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the perimeter and skin contacting portion(s) of Shadduck/Sanchez/Ignon/Ella to be made of a lubricious material as taught by Shadduck because this will make it easier for the user to glide the suctioning device over the patient’s skin, providing a relatively less aggressive dermabrasion.
Regarding claim 47, the modified Shadduck/Sanchez/Ignon/Ella device discloses wherein a surface (outer wall of the perimeter) of the distal tip (110, Figs. 1-2 of Shadduck) has a shape that is at least round (see Fig. 2 of Shadduck, the outer wall of the perimeter of tip 110 is round).
Regarding claim 48, the modified Shadduck/Sanchez/Ignon/Ella device as currently combined is silent regarding wherein a surface of the perimeter portion has a planar configuration.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the perimeter portion of Shadduck/Sanchez/Ignon/Ella to be planar to suit flatter parts of the body, since this is nothing more than one of numerous shapes or configurations a person having ordinary skill in the art would find obvious for the purpose of providing a perimeter portion to form a seal on skin. See MPEP 2144.04(IV)(B).
Furthermore, Ella additionally teaches wherein a surface (distal surface of 20, Figs. 1-2 of Ella) of the perimeter portion has a planar configuration (see Figs. 1-2, the distal surface of 20 appears to be substantially flat) and this is suitable for applying suction massage treatment to the skin.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a surface of the perimeter portion of Shadduck/Sanchez/Ignon/Ella to have a planar configuration as taught by Ella because this change in shape would provide an expected result of a skin applicator that is suitable to apply suction massage treatment to the skin.
Regarding claim 49, the modified Shadduck/Sanchez/Ignon/Ella device discloses wherein a surface (outer rim) of the perimeter portion has a non-planar configuration (the outer rim is slightly curved, see Fig. 3 of Shadduck).
Regarding claim 52, the modified Shadduck/Sanchez/Ignon/Ella device discloses at least one flow channel in the applicator body (flow channel 146, Fig. 2 of Shadduck) communicating with the outlet (port(s) 148, Fig. 2 of Shadduck) in the distal tip (see the first sentence of [0052] of Shadduck).
Regarding claim 53, the modified Shadduck/Sanchez/Ignon/Ella device discloses wherein the at least one flow channel (146) is in fluid communication with the fluid source (fluid source 145, Figs. 1-3 of Shadduck; see the first sentence of [0052] of Shadduck).
Regarding claim 54, the modified Shadduck/Sanchez/Ignon/Ella device discloses wherein a surface (122) of the distal tip (110) is configured for abrading skin (“skin contact surface 122 can carry abrasive elements, such as diamond particles 132 embedded into the surface 122” see lines 9-11 of [0052] of Shadduck).
Regarding claim 55, the modified Shadduck/Sanchez/Ignon/Ella device discloses wherein a surface area of the distal tip is at least 25 mm2 (Shadduck discloses surface areas of skin contact portion 122 as large as 100 mm2, see lines 8-11 of [0049]).
Regarding claim 56, the modified Shadduck/Sanchez/Ignon/Ella device as currently combined is silent regarding further comprising at least one light emitting diode in the applicator body adapted to apply light energy to the targeted tissue to cause stimulation of the targeted tissue.
However, Shadduck additionally teaches an embodiment comprising at least one light emitting diode in the applicator body adapted to apply light energy to the targeted tissue to cause stimulation of the targeted tissue (“the working end can be provided with a source of light energy, such as an LED or a flash lamp or deliver light energy to the patient's skin, for example visible or infrared light. In one variation, a UV light from an LED is provided to kill bacteria” see para. [0078] of Shadduck).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the applicator body of Shadduck/Sanchez/Ignon/Ella to additionally include at least one light emitting diode in the applicator body to apply light energy to the targeted tissue as taught by Shadduck to deliver additional phototherapy to the skin and/or to help kill bacteria with UV light.
Claims 40-44 are rejected under 35 U.S.C. 103 as being unpatentable over Shadduck et al. (US 2018/0303515 A1) in view of Sanchez (WO 01/39717 A1), Ignon et al. (US 2016/0038183 A1), and Ella et al. (US 2004/0260209 A1) as applied to claim 39 above, and further in view of Carava (US 2004/0073144 A1).
Regarding claim 40, the modified Shadduck/Sanchez/Ignon/Ella method does not specifically state applying the fluid media to the targeted tissue prior to moving the distal tip over the targeted tissue.
Carava teaches a related skin suction device (Fig. 1A) wherein the method of operation applies a fluid media to targeted tissue (fluid such as a lubricant or an essential oil, see the second sentence of [0041], the last sentence of [0041], and the first sentence of [0027]) prior to applying the distal tip (receptacle 60, Fig. 3A, Fig. 3C) over the targeted tissue (see the second sentence of [0041] and the last sentence of [0041], the fluid(s) are applied prior to applying the suction device to the skin). This provides an expected result of nourishing the skin and facilitating translation of the applicator over the surface of the skin (see the first sentence of [0034]) and applying the fluid media beforehand allows these benefits to be experienced throughout the entire massage/suctioning method.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Shadduck/Sanchez/Ignon/Ella method to include a fluid media such as an essential oil or lubricant dispensed to the target tissue prior to moving the distal tip over the targeted tissue as taught by Carava because the fluid media provides an expected result of nourishing the skin and facilitating translation of the applicator over the surface of the skin (see the first sentence of [0034]) and applying the fluid media beforehand allows these benefits to be experienced throughout the entire massage/suctioning method.
Regarding claim 41, the modified Shadduck/Sanchez/Ignon/Ella/Carava method discloses wherein the fluid source (145, Shadduck) is at least one of a remote fluid source and a fluid source carried by the applicator (such as 148, Fig. 1 of Shadduck; “FIG. 1 shows the fluid source 145 being remote from the handheld device 100, but it should be appreciated that the device body 105 can be dimensioned to carry a cartridge fluid source indicated at 148 in FIG. 1” see all of para. [0053] of Shadduck).
Regarding claim 42, the modified Shadduck/Sanchez/Ignon/Ella/Carava method discloses wherein the negative pressure causes the fluid media (lubricant/essential oil of Carava) to be absorbed into the tissue of the subject while manipulated (suction is applied to the targeted tissue after the fluid media has been applied to the targeted tissue, and a plurality of roller balls apply a massaging effect as taught by Sanchez. Thus, the same method steps are performed as recited in the claim and the fluid media would be absorbed in substantially the same manner. See also the last ten lines of [0012] of Shadduck, the tissue suctioning method provides “improved absorption of topical skin treatment products”).
Regarding claim 43, the modified Shadduck/Sanchez/Ignon/Ella/Carava method discloses wherein the distal tip (110, Fig. 2 of Shadduck) has an abrasive portion (“skin contact surface 122 can carry abrasive elements, such as diamond particles 132 embedded into the surface 122” see lines 9-11 of [0052] of Shadduck) and wherein moving the distal tip over the targeted tissue abrades the targeted tissue (see lines 9-14 of [0012] of Shadduck).
Regarding claim 44, the modified Shadduck/Sanchez/Ignon/Ella/Carava method as currently combined is silent regarding further comprising activating at least one light emitting diode in the applicator thereby applying light energy to the targeted tissue to cause stimulation of the targeted tissue.
However, Shadduck additionally teaches an embodiment comprising at least one light emitting diode in the applicator body adapted to apply light energy to the targeted tissue to cause stimulation of the targeted tissue (“the working end can be provided with a source of light energy, such as an LED or a flash lamp or deliver light energy to the patient's skin, for example visible or infrared light. In one variation, a UV light from an LED is provided to kill bacteria” see para. [0078] of Shadduck).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Shadduck/Sanchez/Ignon/Ella/Carava to additionally include activating at least one light emitting diode in the applicator to apply light energy to the targeted tissue as taught by Shadduck to deliver additional phototherapy to the skin and/or to help kill bacteria with UV light.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Shadduck et al. (US 2018/0303515 A1) in view of Sanchez (WO 01/39717 A1), Ignon et al. (US 2016/0038183 A1), and Ella et al. (US 2004/0260209 A1) as applied to claim 45 above, and further in view of Chen (CN 111035820 A).
Regarding claim 50, the modified Shadduck/Sanchez/Ignon/Ella device is silent regarding wherein the at least one aspiration channel communicates with a plurality of channels in the plurality of spherical rolling members.
Chen teaches a related facial tissue suctioning device (Fig. 1) having a plurality of spherical rolling members (plurality of spherical rolling balls 323, Fig. 5, are each located in the plurality of cavities 322, Fig. 1) wherein at least one aspiration channel (connecting pipe 2, Fig. 1; “connecting pipe 2 and the vacuum pump are connected with each other” see page 3 of the English translation) communicates with a plurality of channels in a plurality of spherical rolling members (hollow balls 323, Fig. 5, each include a plurality of channels formed by through-holes 3231). The plurality of channels in the spherical rolling members allow blackheads to be sucked through the ball(s) and to a filter provided in the connecting tube (see the last three paragraphs of page 4 of the English translation).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of spherical rolling members of Shadduck/Sanchez/Ignon/Ella to have a plurality of channels in the plurality of spherical rolling members, in communication with at least one aspiration channel as taught by Chen so the tissue suctioning device can additionally suction blackheads from the face.
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Shadduck et al. (US 2018/0303515 A1) in view of Sanchez (WO 01/39717 A1), Ignon et al. (US 2016/0038183 A1), and Ella et al. (US 2004/0260209 A1) as applied to claim 45 above, and further in view of Shadduck (6,641,591)(hereinafter “Shadduck ‘591”).
Regarding claim 57, the modified Shadduck/Sanchez/Ignon/Ella device is silent regarding wherein the distal tip is formed of a transparent material.
Shadduck ‘591 teaches a related skin suction treatment device (Figs. 2-4) wherein the distal tip (working end 20, Figs. 2-4) is formed of a transparent material (“suitable material, such as a transparent medical grade plastic” see col. 4, lines 17-21) to assist the operator to see the targeted tissue treatment area (col. 4, lines 17-21).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip of Shadduck/Sanchez/Ignon/Ella to be formed of a transparent material as taught by Shadduck ‘591 to assist the operator to see the targeted tissue treatment area (col. 4, lines 17-21 of Shadduck ‘591).
Claim 58 is rejected under 35 U.S.C. 103 as being unpatentable over Shadduck et al. (US 2018/0303515 A1) in view of Sanchez (WO 01/39717 A1), Ignon et al. (US 2016/0038183 A1), and Ella et al. (US 2004/0260209 A1) as applied to claim 45 above, and further in view of Ignon et al. (US 2016/0256671 A1)(hereinafter “Ignon ‘671).
Regarding claim 58, the modified Shadduck/Sanchez/Ignon/Ella device is silent regarding wherein the plurality of spherical rolling members (6, taught by Sanchez) include a discontinuity in a surface thereof to allow a flow of the fluid media through the discontinuity.
Ignon ‘671 teaches a related method for manipulating a targeted skin tissue with suction and fluid (using fluid source 640, and “vacuum source (not shown)” in communication with suction ports/passages 628, V, see Fig. 6A and the first sentence of [0081]). Ignon includes a distal applicator tip (620, Fig. 6A) with a plurality of spherical rolling members (rollerball 624, Fig. 6A; which is shown to have a circular cross-section and thus is spherical. Furthermore, this may be “two or more rollerballs” see the first sentence of [0091]). The rolling members facilitate the delivery of fluids to the skin surface as they move to cause rotation of the spherical member(s) relative to said skin surface (see lines 11-14 of [0011]). The rolling member(s) may be removably connected so they can be replaced to change smoothness, texture, porosity, size, or to replace a damaged or used rolling member (see the penultimate sentence of [0061]). Porous rollers and/or textured rollers would include a discontinuity in the surface (pores and/or texture changes) that allow the fluid media to flow at least partially through the pores and/or between textured features.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of spherical rolling members of Shadduck/Sanchez/Ignon/Ella to be removably connected so they can be replaced to change smoothness, texture, porosity, size, etc. as taught by Ignon ‘671 to allow the massaging effect to be customized by selecting different smoothness, texture, porosity, (see the penultimate sentence of [0061] of Ignon). As stated above, the porous roller(s) would allow the fluid media to flow at least partially through the pores and/or between textured features (the discontinuities).
Allowable Subject Matter
The indicated allowability of claim 50 is withdrawn in view of the newly discovered reference(s) to Chen (CN 111035820 A). Rejections based on the newly cited reference(s) are above.
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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Claim 39 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12,114,754 in view of Sanchez (WO 01/39717 A1), Ignon et al. (US 2016/0038183 A1), and Ella et al. (US 2004/0260209 A1).
Regarding application claim 39, patented claim 2 of U.S. Patent No. 12,114,754 discloses a method for treating a targeted tissue (col. 35, lines 14-15) for use with a fluid source (col. 35, lines 21-23), comprising: providing an applicator (col. 35, line 16) and a negative pressure mechanism adapted for applying a negative pressure (col. 35, lines 23-24 and lines 28-30), wherein a distal tip of the applicator has a perimeter portion surrounding an aspiration portion (col. 35, lines 16-17); wherein the aspiration portion includes: i) a receiving space (col. 35, lines 40-42), ii) a plurality of spherical rolling members rotatably located within the receiving space (col. 35, lines 39-42), where a portion of the plurality of spherical rolling members extends distally from a distal periphery of the receiving space (col. 35, lines 18-21), and iv) a fluid inflow channel in fluid communication with the aspiration portion (col. 35, lines 21-24, and lines 36-38, the first port communicating with a fluid source to deliver fluid to hydrate the targeted tissue reads on a fluid inflow channel) such that the fluid inflow channel delivers a fluid media directly to the targeted tissue (col. 35, lines 36-38); contacting the targeted tissue with the distal tip of the applicator (col. 35, lines 25-27); and applying the negative pressure and moving the distal tip over the targeted tissue causing rotation of the plurality of spherical rolling members against the targeted tissue (col. 35, lines 28-35), which manipulates the targeted tissue (col. 35, lines 34-35), wherein activation of the negative pressure mechanism causes the negative pressure to: i) draw a fluid media from the fluid source to the targeted tissue through the fluid inflow channel to hydrate the targeted tissue (col. 35, lines 36-38).
Patented claim 2 of U.S. Patent No. 12,114,754 is silent regarding an aspiration channel within the applicator; the receiving space being within a distal facing surface of the applicator; where a portion of each of the plurality of spherical rolling members extends distally from a distal periphery of the receiving space, iii) a plurality of openings in fluid communication with the aspiration channel, each of the plurality of openings being disposed within the receiving space adjacent to a spherical rolling member of the plurality of spherical rolling members; the fluid inflow channel being outside the receiving space; maintaining the distal tip against the targeted tissue; and activating the negative pressure mechanism draw[s] the fluid media from the targeted tissue into the aspiration channel through the plurality of openings and around one or more of the plurality of spherical rolling members.
Sanchez teaches a related massage suctioning device (Fig. 1, Fig. 5) for applying a negative pressure in an aspiration channel (5a, see annotated Fig. B above) within the applicator (housing 3, Fig. 5), with an aspiration portion (2a, see shaded portion of annotated Fig. B above) including: i) a receiving space (3a, dashed box and blackened structures in annotated Fig. B above. This space receives the ball(s) 6 and suction openings 5) within a distal facing surface (4, Fig. 5) of the applicator, ii) a plurality of spherical rolling members (ball 6, Fig. 5; note that the central ball 6 may have “more than one ball (6)” positioned in the raceway, see page 3, lines 23-24 of the English translation) rotatably located within the receiving space (configured to “rotate in all directions” see page 3, line 22 of the English translation. Furthermore, the ball(s) 6 are located in receiving space 3a as seen in Fig. B above); iii) a plurality of openings (aspiration orifices 5, 5, Fig. 5) in fluid communication with the aspiration channel (5a, see Fig. B above), each of the plurality of openings (5, 5) being disposed within the receiving space (3a, see Fig. B above) adjacent to a spherical rolling member of the plurality of spherical rolling members (each aspiration opening 5, 5, is adjacent a spherical rolling member 6, see Fig. 5). Additionally, movement of the device against the skin will cause rotation of the plurality of spherical members (they are balls configured to “rotate in all directions” see page 3, line 22 of the English translation) against the targeted tissue (the spherical rolling members are placed “in the center of the head” to reduce tension or breaks in the user’s skin during aspiration while also providing massaging effects; see page 3, lines 17-22 of the English translation), which manipulates the targeted tissue (by the ball(s) 6 providing massaging effects).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of patented claim 2 of U.S. Patent No. 12,114,754 to include an aspiration channel, to have the plurality of spherical rolling members rotatably located within the receiving space, and a plurality of openings in fluid communication with the aspiration channel, and adjacent the spherical rolling member(s) that will rotate against the targeted tissue as the device is used as taught by Sanchez so the spherical rollers can be freely rolled along the skin to provide a massage effect and reduce tension or breaks in the user’s skin during aspiration.
The modified Patented claim 2/Sanchez method is still silent regarding a portion of each of the plurality of spherical rolling members extending beyond the distal surface of the perimeter portion; the fluid inflow channel being outside the receiving space; maintaining the distal tip against the targeted tissue; and activation of the negative pressure mechanism draw[s] the fluid media from the targeted tissue into the aspiration channel through the plurality of openings and around one or more of the plurality of spherical rolling members.
Ignon teaches a related fluid delivery and suctioning method (using the device of Fig. 1, which includes a fluid source cartridge 200 and a vacuum hose connection via waste conduit 180, see para. [0107]-[0108]) wherein a fluid inflow channel (fluid delivery channel 122A, Fig. 4) being located outside the receiving space (channel 122A is located adjacent the outer perimeter of the distal tip as seen in Fig. 4, which would be outside the receiving space in the modified method because the plurality of rolling members are located in the central suction channel as taught by Sanchez), the method of use including contacting and maintaining the distal tip against the targeted tissue (see lines 10-16 of [0125]); and wherein activation of a negative pressure mechanism (vacuum source, see the first sentence of [0107]) causes negative pressure to: i) draw a fluid media from the fluid source (cartridge 200 in Fig. 1) to the targeted tissue (skin) through the fluid inflow channel (122A) to hydrate the targeted tissue (“activating a suction source draws a volume of at least one treatment media to the skin surface being treated along the at least one suction region of the tip” see lines 7-9 of [0013]; see also the last sentence of [0109]), and ii) draw the fluid media from the targeted tissue (skin) into the aspiration channel (through waste conduit 180, Fig. 1) through at least one suction opening (“exfoliated skin, spent fluids and/or other waste materials can be transported away from the tip 130 to a canister … the rate of transfer of such waste materials can depend on one or more factors, such as, for example, the setting of the vacuum or suction source, the characteristics … of the various conduits or channels through which the waste materials are conveyed…” see para. [0107]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the location of the fluid inflow channel and the activation of the negative pressure mechanism of patented claim 2 of U.S. Patent No. 12,114,754/Sanchez to have the fluid inflow channel adjacent the perimeter of the distal tip and the negative pressure mechanism being sufficient to cause the negative pressure to i) draw the fluid media from the fluid source to the targeted tissue, and ii) draw the fluid media from the targeted tissue into the aspiration channel as taught by Ignon so exfoliated skin, spent fluids, and/or other waste materials can be suctioned away from the skin and to a waste container.
In the modified Patented claim 2/Sanchez/Ignon method, the step of drawing the fluid media from the targeted tissue into the aspiration channel would occur through the plurality of openings (5, 5) of Sanchez and around one or more of the plurality of spherical rolling members (the openings 5, 5, of Sanchez are on either side of the one or more balls 6 and the aspiration channel extends above the ball(s). The fluid media would be aspirated from the skin near the ball(s) 6, into the orifices 5, 5, and into the aspiration channel, thus the fluid media would transport around the ball(s) 6).
The modified Patented claim 2/Sanchez/Ignon method is still silent regarding a portion of each of the plurality of spherical rolling members extends distally from the distal facing surface.
Ella teaches a related tissue suctioning device for face and body treatment (see Figs. 1A-1G, Fig. 2B, title) that includes a plurality of spherical rolling members (roller 22 includes a plurality of balls 24, Fig. 1F) and at least a portion of each of the plurality of spherical rolling members extends distally (see roller 22 in Fig. 2B) from the distal facing surface (surface 20, Fig. 1A). Ella states that the roller(s) protrude from the distal facing surface (protrudes beyond “proximal end” 11 of surface 20, see Fig. 2B) “for increasing the massaging action to the portion of the body under treatment” (see Fig. 2B and lines 1-4 of [0165]). One of ordinary skill in the art would have recognized that protruding the roller(s) beyond the distal facing surface would provide this increased massaging action, while still substantially reducing the tension in the skin (see Fig. 2A in comparison to Fig. 2B, the presence of the protruding ball(s) 22 in the center of the suction opening in Fig. 2B helps distribute pressure to form two smaller skin bumps 42 rather than a large skin bump 38 in Fig. 2A).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the position of the spherical rolling members (6, Sanchez) of Patented Claim 2/Sanchez/Ignon to have at least a portion of each of the plurality of spherical rolling members extend distally from the distal facing surface as taught by Ella because this provides an increased massaging action, while still substantially reducing the tension in the skin by creating a pair of smaller skin bumps.
Claims 40-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12,114,754 in view of Sanchez (WO 01/39717 A1), Ignon et al. (US 2016/0038183 A1), and Ella et al. (US 2004/0260209 A1) as applied to claim 39 above, and further in view of Carava (US 2004/0073144 A1).
Regarding claim 40, the modified Patented Claim 2/Sanchez/Ignon/Ella method does not specifically state applying the fluid media to the targeted tissue prior to moving the distal tip over the targeted tissue.
Carava teaches a related skin suction device (Fig. 1A) wherein the method of operation applies a fluid media to targeted tissue (fluid such as a lubricant or an essential oil, see the second sentence of [0041], the last sentence of [0041], and the first sentence of [0027]) prior to applying the distal tip (receptacle 60, Fig. 3A, Fig. 3C) over the targeted tissue (see the second sentence of [0041] and the last sentence of [0041], the fluid(s) are applied prior to applying the suction device to the skin). This provides an expected result of nourishing the skin and facilitating translation of the applicator over the surface of the skin (see the first sentence of [0034]) and applying the fluid media beforehand allows these benefits to be experienced throughout the entire massage/suctioning method.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Patented Claim 2/Sanchez/Ignon/Ella method to include a fluid media such as an essential oil or lubricant dispensed to the target tissue prior to moving the distal tip over the targeted tissue as taught by Carava because the fluid media provides an expected result of nourishing the skin and facilitating translation of the applicator over the surface of the skin (see the first sentence of [0034]) and applying the fluid media beforehand allows these benefits to be experienced throughout the entire massage/suctioning method.
Regarding claim 41, the modified Patented Claim 2/Sanchez/Ignon/Ella/Carava method discloses wherein the fluid source is at least one of a remote fluid source and a fluid source carried by the applicator (see col. 35, lines 21-23 of Patented Claim 2, the fluid source is necessarily either remote or carried by the applicator).
Regarding claim 42, the modified Patented Claim 2/Sanchez/Ignon/Ella/Carava method discloses wherein the negative pressure causes the fluid media (lubricant/essential oil of Carava) to be absorbed into the tissue of the subject while manipulated (suction is applied to the targeted tissue after the fluid media has been applied to the targeted tissue, and a plurality of roller balls apply a massaging effect as taught by Sanchez. Additionally, see col. 35, lines 28-38 of Patented Claim 2, the tissue is hydrated by having the fluid media absorbed into the tissue).
Regarding claim 43, the modified Patented Claim 2/Sanchez/Ignon/Ella/Carava method as currently combined is silent regarding wherein the distal tip has an abrasive portion and wherein moving the distal tip over the targeted tissue abrades the targeted tissue.
However, Ignon additionally teaches that its distal tip includes an abrasive portion and wherein moving the distal tip over the targeted tissue abrades the targeted tissue (see lines 1-5 of [0015]) to provide microdermabrasion treatment to exfoliate skin and remove waste (see lines 1-9 of [0037]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip of Patented Claim 2/Sanchez/Ignon/Ella/Carava to include an abrasive portion and wherein moving the distal tip over the targeted tissue abrades the targeted tissue as taught by Ignon to provide microdermabrasion treatment to exfoliate skin and remove waste.
Regarding claim 44, the modified Patented Claim 2/Sanchez/Ignon/Ella/Carava method as currently combined is silent regarding activating at least one light emitting diode in the applicator thereby applying light energy to the targeted tissue to cause stimulation of the targeted tissue.
Ignon further teaches that the method may include activating at least one light emitting diode in the applicator (light wands in Fig. 6A-6B, which may include LEDs as stated in para. [0134], are incorporated into a handpiece that is performing microdermabrasion as stated in the first two sentences of [0131]) thereby applying light energy to the targeted tissue to cause stimulation of the targeted tissue (to at least partially modify or affect at a cellular level, the skin and tissue of the subject such as to enable the pores of the subject to open or dilate to allow serums or other treatment fluids to penetrate deeper into the skin, see all of [0134]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Patented Claim 2/Sanchez/Ignon/Ella/Carava method to additionally activate at least one light emitting diode in the applicator thereby applying light energy to the targeted tissue as taught by Ignon in order to at least partially modify or affect at a cellular level, the skin and tissue of the subject such as to enable the pores of the subject to open or dilate to allow serums or other treatment fluids to penetrate deeper into the skin.
Claims 45, 47-50, 52-54, 56, and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,324,500 in view of Sanchez (WO 01/39717 A1), Ignon et al. (US 2016/0038183 A1), and Ella et al. (US 2004/0260209 A1).
Regarding application claim 45, patented claim 17 of U.S. Patent No. 12,324,500 discloses a device for treating a targeted tissue of a subject (col. 26, lines 39-40), the device comprising: an applicator body (col. 26, line 41); a negative pressure mechanism (negative pressure source, col. 26, lines 41-42); a distal tip of the applicator body having a perimeter portion configured for contacting the targeted tissue (col. 26, lines 44-45), wherein the perimeter portion surrounds an aspiration portion (col. 26, lines 46-53, the recessed region includes an aspiration portion), wherein the aspiration portion comprises a receiving space (col. 26, lines 48-49, the space each rolling member is located in); a plurality of spherical rolling members rotatably located within the receiving space (col. 26, lines 47-50); at least one aspiration channel configured for applying a negative pressure from the negative pressure mechanism (col. 26, lines 51-58, the plurality of channels form an aspiration portion); and a plurality of openings in fluid communication with the at least one aspiration channel (col. 26, lines 51-58, the plurality of apertures distributed over the aspiration portion), each of the plurality of openings being disposed within the receiving space (col. 26, lines 47-58, the plurality of apertures are distributed over the aspiration portion), wherein moving the distal tip over the targeted tissue causes rotation of the plurality of spherical rolling members against the targeted tissue, which manipulates the targeted tissue (col. 26, line 66 through col. 27, line 1, and this rolling against the tissue necessarily manipulates tissue to some degree),
Patented claim 17 of U.S. Patent No. 12,324,500 is silent regarding where a portion of each of the plurality of spherical rolling members extends distally from the distal facing surface; each of the plurality of openings being adjacent to a spherical rolling member of the plurality of spherical rolling members; and wherein activation of the negative pressure mechanism causes the negative pressure to: i) draw a fluid media from a fluid source to the targeted tissue through an outlet in the aspiration portion outside the receiving space when contacting the targeted tissue such that the outlet delivers the fluid media directly to the targeted tissue, and ii) draw the fluid media from the targeted tissue into the at least one aspiration channel through the plurality of openings and around one or more of the plurality of spherical rolling members.
Sanchez teaches a related massage suctioning device (Fig. 1, Fig. 5) with an aspiration portion (2a, see shaded portion of annotated Fig. B above) that comprises a receiving space (3a, dashed box and blackened structures in annotated Fig. B above. This space receives the ball(s) 6 and suction openings 5); a plurality of spherical rolling members (ball 6, Fig. 5; note that the central ball 6 may have “more than one ball (6)” positioned in the raceway, see page 3, lines 23-24 of the English translation) rotatably located within the receiving space (configured to “rotate in all directions” see page 3, line 22 of the English translation. Furthermore, the ball(s) 6 are located in receiving space 3a as seen in Fig. B above); at least one aspiration channel (5a, see Fig. B above) configured for applying a negative pressure from the negative pressure mechanism; and a plurality of openings (aspiration orifices 5, 5, Fig. 5) in fluid communication with the at least one aspiration channel (5a, see Fig. B above), each of the plurality of openings (5, 5) being disposed within the receiving space (3a, see Fig. B above) adjacent to a spherical rolling member of the plurality of spherical rolling members (each aspiration opening 5, 5, is adjacent a spherical rolling member 6, see Fig. 5). Additionally, movement of the device against the skin will cause rotation of the plurality of spherical members (they are balls configured to “rotate in all directions” see page 3, line 22 of the English translation) against the targeted tissue (the spherical rolling members are placed “in the center of the head” to reduce tension or breaks in the user’s skin during aspiration while also providing massaging effects; see page 3, lines 17-22 of the English translation), which manipulates the targeted tissue (by the ball(s) 6 providing massaging effects).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of patented claim 17 of U.S. Patent No. 12,324,500 to include an aspiration channel, to have the plurality of spherical rolling members rotatably located within the receiving space, and a plurality of openings in fluid communication with the at least one aspiration channel, and adjacent to the spherical rolling member(s) that will rotate against the targeted tissue as the device is used as taught by Sanchez so the spherical rollers can be freely rolled along the skin to provide a massage effect and reduce tension or breaks in the user’s skin during aspiration.
The modified Patented Claim 17/Sanchez device is still silent regarding wherein a portion of each of the plurality of spherical rolling members extends distally from the distal facing surface; activation of the negative pressure mechanism causes the negative pressure to: i) draw a fluid media from a fluid source to the targeted tissue through an outlet in the aspiration portion outside the receiving space when contacting the targeted tissue such that the outlet delivers the fluid media directly to the targeted tissue, and ii) draw the fluid media from the targeted tissue into the at least one aspiration channel through the plurality of openings and around one or more of the plurality of spherical rolling members.
Ignon teaches a related fluid delivery and suctioning device (Fig. 1, which includes a fluid source cartridge 200 and a vacuum hose connection via waste conduit 180, see para. [0107]-[0108]) wherein activation of a negative pressure mechanism (vacuum source, see the first sentence of [0107]) causes negative pressure to: i) draw a fluid media from the fluid source (cartridge 200 in Fig. 1) to the targeted tissue (skin) through an outlet (outlet of fluid delivery channel 122A, Fig. 4) in the aspiration portion (“activating a suction source draws a volume of at least one treatment media to the skin surface being treated along the at least one suction region of the tip” see lines 7-9 of [0013]; see also the last sentence of [0109]) outside the receiving space (channel 122A is located adjacent the outer perimeter of the distal tip as seen in Fig. 4, which would be outside the receiving space in the modified method because the plurality of rolling members are located in the central suction channel as taught by Sanchez) when contacting the targeted tissue such that the outlet (122A) delivers the fluid media directly to the targeted tissue (see lines 7-9 of [0013]), and ii) draw the fluid media from the targeted tissue (skin) into the at least one aspiration channel (through waste conduit 180, Fig. 1) through at least one suction opening (“exfoliated skin, spent fluids and/or other waste materials can be transported away from the tip 130 to a canister … the rate of transfer of such waste materials can depend on one or more factors, such as, for example, the setting of the vacuum or suction source, the characteristics … of the various conduits or channels through which the waste materials are conveyed…” see para. [0107]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the location of the fluid inflow channel and the activation of the negative pressure mechanism of patented claim 17 of U.S. Patent No. 12,324,500/Sanchez to have the fluid inflow channel adjacent the perimeter of the distal tip and the negative pressure mechanism being sufficient to cause the negative pressure to i) draw the fluid media from the fluid source to the targeted tissue, and ii) draw the fluid media from the targeted tissue into the aspiration channel as taught by Ignon so exfoliated skin, spent fluids, and/or other waste materials can be suctioned away from the skin and to a waste container.
In the modified Patented Claim 17/Sanchez/Ignon device, the drawing the fluid media from the targeted tissue into the at least one aspiration channel would occur through the plurality of openings (5, 5) of Sanchez and around one or more of the plurality of spherical rolling members (the openings 5, 5, of Sanchez are on either side of the one or more balls 6 and the aspiration channel extends above the ball(s). The fluid media would be aspirated from the skin near the ball(s) 6, into the orifices 5, 5, and into the aspiration channel, thus the fluid media would transport around the ball(s) 6).
The modified Patented Claim 17/Sanchez/Ignon device is still silent regarding a portion of each of the plurality of spherical rolling members extends distally from the distal facing surface.
Ella teaches a related tissue suctioning device for face and body treatment (see Figs. 1A-1G, Fig. 2B, title) that includes a plurality of spherical rolling members (roller 22 includes a plurality of balls 24, Fig. 1F) and at least a portion of each of the plurality of spherical rolling members extends distally (see roller 22 in Fig. 2B) from the distal facing surface (surface 20, Fig. 1A). Ella states that the roller(s) protrude from the distal facing surface (protrudes beyond “proximal end” 11 of surface 20, see Fig. 2B) “for increasing the massaging action to the portion of the body under treatment” (see Fig. 2B and lines 1-4 of [0165]). One of ordinary skill in the art would have recognized that protruding the roller(s) beyond the distal facing surface would provide this increased massaging action, while still substantially reducing the tension in the skin (see Fig. 2A in comparison to Fig. 2B, the presence of the protruding ball(s) 22 in the center of the suction opening in Fig. 2B helps distribute pressure to form two smaller skin bumps 42 rather than a large skin bump 38 in Fig. 2A).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the position of the spherical rolling members (6, Sanchez) of Patented Claim 17/Sanchez/Ignon to have at least a portion of each of the plurality of spherical rolling members extend distally from the distal facing surface as taught by Ella because this provides an increased massaging action, while still substantially reducing the tension in the skin by creating a pair of smaller skin bumps.
Regarding claim 48, the modified Patented Claim 17/Sanchez/Ignon/Ella device as currently combined is silent regarding wherein a surface of the perimeter portion has a planar configuration.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the perimeter portion of Patented Claim 17/Sanchez/Ignon/Ella to be planar to suit flatter parts of the body, since this is nothing more than one of numerous shapes or configurations a person having ordinary skill in the art would find obvious for the purpose of providing a perimeter portion to form a seal on skin. See MPEP 2144.04(IV)(B).
Furthermore, Sanchez additionally teaches wherein a surface (distal surface) of the perimeter portion has a planar configuration (see Figs. 1-2, the distal surface of the perimeter is substantially flat) and this is suitable for applying suction massage treatment to the skin.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a surface of the perimeter portion of Patented Claim 17/Sanchez/Ignon/Ella device to have a planar configuration as taught by Sanchez because this change in shape would provide an expected result of a skin applicator that is suitable to apply suction massage treatment to the skin.
Regarding claim 49, the modified Patented Claim 17/Sanchez/Ignon/Ella device as currently combined is silent regarding wherein a surface of the perimeter portion has a non-planar configuration.
Ignon additionally teaches that a surface of the perimeter portion has a non-planar configuration (head 630 includes a circular or rounded outer shape, see the first two sentences of [0142]), which would provide an expected result of treating a rounded/circular area of tissue.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a surface of the perimeter portion of Patented Claim 17/Sanchez/Ignon/Ella to be rounded (non-planar) as taught by Ignon because this is expected to be suitable to treat rounded/circular areas of tissue.
Regarding claim 50, the modified Patented Claim 17/Sanchez/Ignon/Ella device discloses wherein the at least one aspiration channel communicates with a plurality of channels in the plurality of spherical rolling members (see col. 26, lines 51-58 of 12,324,500).
Regarding claim 52, the modified Patented Claim 17/Sanchez/Ignon/Ella device discloses at least one flow channel in the applicator body (fluid delivery channel 122A, Fig. 4 of Ignon) communicating with the outlet in the distal tip (the distal opening of the fluid delivery channel 122A, Fig. 4 of Ignon).
Regarding claim 53, the modified Patented Claim 17/Sanchez/Ignon/Ella device discloses wherein the at least one flow channel (122A, Ignon) is in fluid communication with the fluid source (such as fluid source cartridge 200 of Ignon, see Figs. 1-2 and para. [0121] of Ignon).
Regarding claim 54, the modified Patented Claim 17/Sanchez/Ignon/Ella device as currently combined is silent regarding wherein a surface of the distal tip is configured for abrading skin.
However, Ignon additionally teaches that a surface of its distal tip includes an abrasive portion and wherein moving the distal tip over the targeted tissue abrades the targeted tissue (see lines 1-5 of [0015]) to provide microdermabrasion treatment to exfoliate skin and remove waste (see lines 1-9 of [0037]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip of Patented Claim 17/Sanchez/Ignon/Ella to include an abrasive surface as taught by Ignon to provide microdermabrasion treatment to exfoliate skin and remove waste.
Regarding claim 56, the modified Patented Claim 17/Sanchez/Ignon/Ella device as currently combined is silent regarding further comprising at least one light emitting diode in the applicator body adapted to apply light energy to the targeted tissue to cause stimulation of the targeted tissue.
Ignon further teaches that the device may include at least one light emitting diode in the applicator body (light wands in Fig. 6A-6B, which may include LEDs as stated in para. [0134], are incorporated into a handpiece that is performing microdermabrasion as stated in the first two sentences of [0131]) adapted to apply light energy to the targeted tissue to cause stimulation of the targeted tissue (to at least partially modify or affect at a cellular level, the skin and tissue of the subject such as to enable the pores of the subject to open or dilate to allow serums or other treatment fluids to penetrate deeper into the skin, see all of [0134]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Patented Claim 17/Sanchez/Ignon/Ella device to additionally activate at least one light emitting diode in the applicator thereby applying light energy to the targeted tissue as taught by Ignon in order to at least partially modify or affect at a cellular level, the skin and tissue of the subject such as to enable the pores of the subject to open or dilate to allow serums or other treatment fluids to penetrate deeper into the skin.
Regarding claim 58, the modified Patented Claim 17/Sanchez/Ignon/Ella device discloses wherein the plurality of spherical rolling members include a discontinuity in a surface thereof to allow a flow of the fluid media through the discontinuity (see col. 26, lines 51-58 of 12,324,500, the plurality of apertures are a discontinuity, which would “allow” at least some amount of the fluid media to flow through).
Claims 46 and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,324,500 in view of Sanchez (WO 01/39717 A1), Ignon et al. (US 2016/0038183 A1), and Ella et al. (US 2004/0260209 A1) as applied to claim 45 above, and further in view of Shadduck et al. (US 2018/0303515 A1).
Regarding claim 46, the modified Patented Claim 17/Sanchez/Ignon/Ella device as currently combined is silent regarding wherein the perimeter portion comprises a lubricious material.
Shadduck teaches a related tissue suctioning device (Fig. 1) wherein the applicator tip (610, Fig. 16) may include a skin interface of a lubricious molded silicone or similar elastomer (see the second sentence of [0085]). This would provide an expected result of allowing the skin interface, including the perimeter portion, to move across the skin relatively easier, for less aggressive dermabrasion (see lines 10-15 of [0052]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the perimeter portion and skin contacting portion(s) of Patented Claim 17/Sanchez/Ignon/Ella to be made of a lubricious material as taught by Shadduck because this will make it easier for the user to glide the suctioning device over the patient’s skin, providing a relatively less aggressive dermabrasion.
Regarding claim 55, the modified Patented Claim 17/Sanchez/Ignon/Ella device as currently combined is silent regarding wherein a surface area of the distal tip is at least 25 mm2.
Shadduck teaches a related tissue suctioning device (Fig. 1) in which a surface area of the distal tip is at least 25 mm2 (skin contact portion 122 may be as large as 100 mm2, see lines 8-14 of [0049]), to be suited to treat different parts of the body such as the face (see lines 8-14 of [0049]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the surface area of the distal tip of Patented Claim 17/Sanchez/Ignon/Ella to be at least 25 mm2 as taught by Shadduck because this would be expected to be suitable for treating facial skin and/or other smaller areas of the body.
Claim 57 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,324,500 in view of Sanchez (WO 01/39717 A1), Ignon et al. (US 2016/0038183 A1), and Ella et al. (US 2004/0260209 A1) as applied to claim 45 above, and further in view of Shadduck (6,641,591)( “Shadduck ‘591”).
Regarding claim 57, the modified Patented Claim 17/Sanchez/Ignon/Ella device is silent regarding wherein the distal tip is formed of a transparent material.
Shadduck ‘591 teaches a related skin suction treatment device (Figs. 2-4) wherein the distal tip (working end 20, Figs. 2-4) is formed of a transparent material (“suitable material, such as a transparent medical grade plastic” see col. 4, lines 17-21) to assist the operator to see the targeted tissue treatment area (col. 4, lines 17-21).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip of Patented Claim 17/Sanchez/Ignon/Ella to be formed of a transparent material as taught by Shadduck ‘591 to assist the operator to see the targeted tissue treatment area (col. 4, lines 17-21 of Shadduck ‘591).
Response to Arguments
Applicant's arguments filed March 16, 2026, have been fully considered but they are not persuasive.
Regarding the argument that claim 39 has been amended consistent with the Examiner’s suggestion to overcome the objection (see the second paragraph of page 7 of the Remarks), this argument is not persuasive because the claim has not been amended to address the objection.
Regarding the argument that the balls (6) shown in Sanchez’s Fig. 5 do not extend distally from the distal facing surface (see the first paragraph of page 8 of the Remarks), this argument has been considered, but it is moot because Sanchez has been further modified by Ella et al. (US 2004/0260209 A1) in the current rejection(s) to have the plurality of rolling members extend distally for an increased massaging effect.
Regarding the argument that having a portion of Sanchez’s ball(s) (6) extend distally to a distal facing surface of the applicator would run contrary to Sanchez’ explicit teaching that no part of the ball would touch a horizontal plane formed by the applicator head (see the first paragraph of page 9 of the Remarks), this argument is not persuasive. Sanchez has one or more roller balls (6, Fig. 5) that are placed “in the center of the head” for the purpose of reducing “tension or breaks in the user’s skin” during aspiration while also providing massaging effects (see page 3, lines 17-22 of the English translation of Sanchez). As long as the ball(s) (6) are located centrally, they will reduce tension in the user’s skin, as is shown in Figs. 2A-2B of Ella (the presence of the protruding ball(s) 22 in the center of the suction opening in Fig. 2B helps distribute pressure to form two smaller skin bumps 42 rather than a large skin bump 38 in Fig. 2A).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHRISTOPHER E MILLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785