DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/16/2025 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/6/2025, 12/16/2025, 1/13/2026 and 2/13/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Applicant's arguments filed 12/16/2025 have been fully considered but they are not persuasive.
Regarding independent claims 1 and 44, Applicant contends that none of either Austen or Carrison expressly discloses, teaches or suggests the amended limitations of “wherein the spaced includes a vacuum spacer including a frame to contact the surface of the skin tissue, wherein the frame comprises a base, an inner wall and an outer wall, wherein the base, the inner wall and the outer wall form a channel within the frame, wherein the channel is configured such that when the frame is placed on the surface of the skin, the surface of the skin, the base, the inner wall and the outer wall form a frame lumen, and wherein the frame is connected to a fluid conduit such that when low pressure or vacuum is applied to the fluid conduit, low pressure or vacuum is established in the frame lumen, thereby drawing skin tissue toward and/or into the channel”. This is on the grounds that Austen, even when modified by Carrison, does not disclose a frame having a base, inner wall and outer wall that together form an open channel in the frame such that the vacuum pressure may be applied through the frame conduit to the surface of the skin. The device of Austen lacks any capacity for establishing low pressure or vacuum in a frame lumen that is formed of a base, an inner wall and an outer wall together with the surface of the skin with which the frame may be placed in contact. Carrison fails to remedy this lack of frame structure providing the necessary vacuum channel.
The Examiner respectfully disagrees with Applicant’s interpretation of the combined references. In an updated rejection of the amended claims 1 and 44 below, Austen discloses a frame (exterior structural frame of the “Spacer Portion” as designate in Examiner’s Diagram of Fig. 4A below) to contact the surface of the skin tissue (see Para. [0014] mentioning wherein the housing (400) is configured to contact, stretch and/or stabilize tissue when placed thereon);
wherein the frame comprises a base (bottom-most portion of the housing that contacts tissue, see Examiner’s Diagram of Fig. 4A below), an inner wall (radially-inward wall of the “Spacer Portion” facing “substrate 130” as shown in Examiner’s Diagram of Fig. 4A below), and an outer wall (radially-outward wall of the “Spacer Portion” facing the exterior environment as shown in Examiner’s Diagram of Fig. 4A below).
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Examiner’s Diagram of Fig. 4A
While Austen does not expressly disclose wherein the base, inner wall and outer wall of the frame define a vacuum conduit therethrough such that a fluid conduit can be connected thereto to allow low pressure or vacuum to be established in the frame lumen to draw skin tissue toward and/or into the channel, Carrison provides a teaching of a tissue treatment device (treatment device 700, see Figs. 7A-7E) comprising tissue-contacting vacuum spacer (spacer 704 and anchor 706 which are connected together and define a “Spacer” structure, see Figs. 7A-7E and Para. [0082]-[0084]) comprising a base (distal-most portion of anchor 706, see Examiner’s Diagram of Carrison Fig. 7A below), an inner wall (radially-inward wall portion of the spacer (704) facing the vacuum lumen 712/722, see Examiner’s Diagram of Carrison Fig. 7A below) and an outer wall (radially-outward portion of the spacer facing exterior of the device as shown in Examiner’s Diagram of Carrison Fig. 7A below) which form a channel within the “Spacer” (vacuum lumen 712 and spacer lumen 722, see Fig. 7A); wherein the channel is configured such that when the frame is placed on the surface of the skin, the surface of the skin, the base, the inner wall and the outer wall form a frame lumen (vacuum lumen 712/spacer lumen 722 and vacuum openings 724, see Fig. 7A and Para. [0082]-[0084]); and
wherein the frame is connected to a fluid conduit such that when low pressure or vacuum is applied to the fluid conduit, low pressure or vacuum is established in the frame lumen (vacuum tubing 752, see Fig. 7D and Para. [0084]), thereby drawings skin tissue toward and/or into the channel (see Para. [0082]-[0084]).
In incorporating the teachings and associated required structure of Carrison into the device of Austen to provide a vacuum system allowing better adhesion of the treatment device to a target tissue, the “base”, “inner wall” and “outer wall” of the frame of Austen would define a lumen through the device to allow connection of a vacuum source to be connected thereto such that an applied vacuum can be applied through the newly-defined “frame lumen” to draw the target tissue into the vacuum channel at the “base” of the frame, thereby better and more securely adhering the device of Austen to the target site for further procedures to take place.
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Examiner’s Diagram of Carrison Fig. 7A
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.
Claim(s) 1-10, 12-13, 18, 22, 26-36, 38-39 and 43-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austen (WO 2012/103492 A1)(previously of record) in view of Carrison (US 2018/0236146 A1)(previously of record).
Regarding claim 1, Austen discloses:
An apparatus (apparatus 400, see Fig. 4A) for producing a cosmetic effect in skin tissue, the apparatus comprising:
(i) a needle hub (substrate 130, see Fig. 4B, see also Para. [0014]) comprising at least one hollow needle (needle 120, see Fig. 4A/4B) having a distal end for contacting skin and configured to remove a portion of the skin tissue when the hollow needle is inserted into and withdrawn from the skin tissue (see Abstract, Para. [0002]-[0020] and Figs. 4A-5D);
(ii) a translation and/or actuation mechanism (reciprocating arrangement 420, see Fig. 4A/4B) connected to the needle hub (see Figs. 4A/4B) to translate and/or actuate the needle hub in one or more directions relative to a surface of the skin tissue (see Figs. 4A-4B, see also Para. [0058]); and
(iii) a spacer (distal end of 400, see Examiner’s Diagram of Austen Fig. 4A below) to stabilize and/or maintain a constant position of the apparatus relative to the surface of the skin tissue (spacing of holes (220) in tissue can be determined, e.g., by reciprocating frequency and/or translational speed of the apparatus (400) over tissue surface. Fig. 4A shows the “spacer” maintains distance to the skin surface and stabilizes the device thereon, see also Para. [0014]); wherein the spacer includes:
a frame (exterior structural frame of the “Spacer Portion” as designate in Examiner’s Diagram of Fig. 4A below) to contact the surface of the skin tissue (see Para. [0014] mentioning wherein the housing (400) is configured to contact, stretch and/or stabilize tissue when placed thereon);
wherein the frame comprises a base (bottom-most portion of the housing that contacts tissue, see Examiner’s Diagram of Fig. 4A below), an inner wall (radially-inward wall of the “Spacer Portion” facing “substrate 130” as shown in Examiner’s Diagram of Fig. 4A below), and an outer wall (radially-outward wall of the “Spacer Portion” facing the exterior environment as shown in Examiner’s Diagram of Fig. 4A below).
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Examiner’s Diagram of Fig. 4A
However, Austen does not expressly disclose:
Wherein the spacer is a vacuum spacer;
wherein the base, the inner wall and the outer wall form a channel in the frame;
wherein the channel is configured such that when the frame is placed on the surface of the skin, the surface of the skin, the base, the inner wall and the outer wall form a frame lumen; and
wherein the frame is connected to a fluid conduit such that when low pressure or vacuum is applied to the fluid conduit, low pressure or vacuum is established in the frame lumen, thereby drawings skin tissue toward and/or into the channel.
In an analogous field of endeavor, namely tissue-treatment devices configured to be adhered to and/or in direct contact with tissue, Carrison discloses a tissue treatment device (treatment device 700, see Figs. 7A-7E) comprising tissue-contacting vacuum spacer (spacer 704 and anchor 706 which are connected together and define a “Spacer” structure, see Figs. 7A-7E and Para. [0082]-[0084]) comprising a base (distal-most portion of anchor 706, see Examiner’s Diagram of Carrison Fig. 7A below), an inner wall (radially-inward wall portion of the spacer (704) facing the vacuum lumen 712/722, see Examiner’s Diagram of Carrison Fig. 7A below) and an outer wall (radially-outward portion of the spacer facing exterior of the device as shown in Examiner’s Diagram of Carrison Fig. 7A below) which form a channel within the “Spacer” (vacuum lumen 712 and spacer lumen 722, see Fig. 7A); wherein the channel is configured such that when the frame is placed on the surface of the skin, the surface of the skin, the base, the inner wall and the outer wall form a frame lumen (vacuum lumen 712/spacer lumen 722 and vacuum openings 724, see Fig. 7A and Para. [0082]-[0084]); and
wherein the frame is connected to a fluid conduit such that when low pressure or vacuum is applied to the fluid conduit, low pressure or vacuum is established in the frame lumen (vacuum tubing 752, see Fig. 7D and Para. [0084]), thereby drawings skin tissue toward and/or into the channel (see Para. [0082]-[0084]).
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Examiner’s Diagram of Carrison Fig. 7A
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 the “Spacer Portion” of the apparatus (400) of Austen to comprise a vacuum channel/lumen extending therethrough, between the “inner wall” and “outer wall” and terminating at one or more vacuum openings within the “base” as taught and suggested by Carrison to, in this case, allow a user to apply a vacuum through the frame of the housing to the tissue-contacting surface of the “base” which would aid in securing the device to the skin via the applied suction force (see Carrison Para. [0082]-[0084]).
Regarding claim 2, the combination of Austen and Carrison discloses the invention of claim 1, Austen further discloses a hand piece shell (see Examiner’s Diagram of Austen Fig. 4A above showing a hand shell piece) at least partially enclosing the translation and/or actuation mechanism (see Fig. 4A showing reciprocating arrangement (420) disposed within the designated hand shell piece).
Regarding claim 3, the combination of Austen and Carrison discloses the invention of claim 2, Austen further discloses wherein the spacer is attached to the hand piece shell (see Fig. 4A).
Regarding claim 4, the combination of Austen and Carrison discloses the invention of claim 1, Austen further discloses wherein the needle hub comprises a single hollow needle (see Figs. 4A showing a single needle, see also Fig. 4B showing a plurality of hollow needles – the language of the claims does not recite “only” or “no more than” a single needle and thus so long as at least one needle is present, the limitation is met by Austen).
Regarding claim 5, the combination of Austen and Carrison discloses the invention of claim 1, Austen further discloses wherein the needle hub comprises three hollow needles arranged in a row (see Fig. 4B).
Regarding claim 6, the combination of Austen and Carrison discloses the invention of claim 1, Austen further discloses wherein the needle hub comprises a two dimensional array of needles (see Fig. 4B).
Regarding claim 7, the combination of Austen and Carrison discloses the invention of claim 1, Austen further discloses wherein the needle hub comprises a first lumen (lumen of needle (120)) having a first end (distal-most portion) and a second end (proximal-most portion), wherein the first lumen comprises a lumen of the at least one hollow needle (lumen of needle (120), see Fig. 6) and wherein the first end of the first lumen is at the distal end of the hollow needle (see Fig. 6).
Regarding claim 8, the combination of Austen and Carrison discloses the invention of claim 7, Austen further discloses wherein the needle hub comprises a second lumen (lumen of conduit 620, see Fig. 6) having a wall (outer housing of the conduit 620, see Fig. 6), a first end (proximal-most point of the lumen of conduit 620, see Fig. 6), and a second end (distal-most point in which a needle is disposed), wherein the first end of the second lumen is or comprises a fluid intake nozzle (see Fig. 6 showing wherein a vacuum intake is formed connecting a vacuum source to the proximal end of each respective needle disposed within the lumens of the substrate, see also Para. [0071]).
Regarding claim 9, the combination of Austen and Carrison discloses the invention of claim 8, Austen further discloses wherein the first lumen is connected to the second lumen (see Fig. 6) such that the second end of the first lumen forms an opening in the wall of the second lumen (see Fig. 6, Para. [0071]-[0074]).
Regarding claim 10, the combination of Austen and Carrison discloses the invention of claim 9, Austen further discloses wherein each of the first lumen and the second lumen are substantially straight (see Fig. 6), and wherein the first lumen is substantially perpendicular to the second lumen forming a T-junction (see Fig. 6 and Para. [0071]-[0074]).
Regarding claim 12, the combination of Austen and Carrison discloses the invention of claim 9, Austen further discloses wherein the second end of the second lumen is connected to a fluid conduit such that when low pressure or vacuum is applied to the conduit, low pressure or vacuum is induced in the first lumen and the second lumen, such that fluid is drawn into and through the second lumen through the first end of the second lumen, thereby clearing skin tissue from the first lumen (see Para. [0071] mentioning wherein a conduit (620) is connectable to a source of low pressure (not shown) that would transmit through the conduit, through the first and second lumen to the distal tip of the needles adhere them the skin).
Regarding claim 13, the combination of Austen and Carrison discloses the invention of claim 1, Austen further discloses wherein the translation and/or actuation mechanism comprises an actuator (roller 330, see Fig. 3A) to displace the needle hub along a z-axis in a direction substantially perpendicular to a surface of the skin tissue (actuator (330) moves perpendicular to the skin as it rolls, see Fig. 3A) and substantially parallel to a longitudinal axis of the at least one hollow needle (Fig. 3A shows needle (120) pointed parallel to skin making the perpendicular motion of roller (330) substantially parallel to a longitudinal axis of the needle, see Fig 6).
Regarding claim 17, the combination of Austen and Carrison discloses the invention of claim 1, Austen further discloses wherein the translation and/or actuation mechanism comprises a rotary stage to rotate the needle hub (needles are attached to the outside of the substrate, see Fig. 3A) around a z-axis (needles can be provided on a roller arrangement (i.e., a cylindrical base) configured to rotate about its longitudinal axis, see Para. [0010], see also Fig. 3A).
Regarding claim 18, the combination of Austen and Carrison discloses the invention of claim 1, Austen further discloses wherein the spacer comprises a device to contact a surface of the skin tissue (distal end of the “spacer” as defined in Examiner’s Diagram of Fig. 4A above that contacts tissue when placed against, see also Abstract), and to (a) to maintain a distance and/or position between the apparatus and the skin tissue and/or (b) maintain or increase tension in the skin tissue during treatment compared to the skin tissue not being treated and/or contacted by an apparatus (the housing (430) can be configured to stretch skin or other tissue when the exemplary apparatus (400) is placed on the tissue to be treated. Such exemplary stretching can facilitate mechanical stabilization of the tissue, e.g., such that the one or more needles (120) can more easily be inserted and/or withdrawn from the tissue, while reducing or avoiding deformation of the tissue area being treated, see Para. [0061]).
Regarding claim 22, the combination of Austen and Carrison discloses the invention of claim 1, Austen, as modified by Carrison, further disclose wherein the base comprises one or more protrusions (radially-inward protruding arms extending laterally from the labeled “base” of the support portion, see Examiner’s Diagram of Fig. 4A above).
Regarding claim 26, the combination of Austen and Carrison discloses the invention of claim 1, Austen further discloses the system comprising a removal system for removing one or more tissue portions from the apparatus (the low pressure in the conduit (620) can generate a suction in the needles (120), which can facilitate insertion of the needles into the tissue being treated. Extraction of the tissue portions from the surrounding tissue and/or removal of such tissue portions from the lumen of the needles after the needles are withdrawn from the tissue, see Para. [0071]).
Regarding claim 27, the combination of Austen and Carrison discloses the invention of claim 26, Austen further discloses wherein the removal system comprises a low pressure source (the conduit (620) can be connected to a source of low pressure (i.e., a vacuum), see Para. [0071]).
Regarding claim 28, the combination of Austen and Carrison discloses the invention of claim 27, Austen further discloses wherein the low pressure source is connected to the needle hub comprising the at least one hollow needle via a first conduit to provide suction in the at least one hollow needle (see Fig. 6).
Regarding claim 29, the combination of Austen and Carrison discloses the invention of claim 28, Austen, as modified by Carrison, further discloses wherein the low pressure source is connected to the spacer via a second conduit to provide suction in the spacer (upon the incorporation of suction applied to the “Spacer Portion” from the teachings of Carrison, the low pressure source would be connected to both the needle conduit, in addition to the “Spacer Portion” lumen to allow for suction to be applied thereto in keeping with the disclosure of Austen and the teachings of Carrison).
Regarding claim 30, the combination of Austen and Carrison discloses the invention of claim 1, Austen further discloses wherein the at least one hollow needle comprises at least a first prong provided at a distal end of the hollow needle for contacting skin (see Fig. 5B), wherein an angle between a lateral side of the first prong and a longitudinal axis of the hollow needle may be less than 90 degrees, depending on the amount of prongs present (the specification defines “at least 20 degrees” as “e.g., the bevel angle may be greater than about 20 degrees” (Specification Para. [0248]) and Austen discloses wherein the prongs of the needles may be at an angle of less than 90 degrees. Fig. 5B shows prongs with a bevel angle greater than about 20 degrees, see Austen Para. [0065]).
Therefore, while Austen does not expressly disclose wherein an angle between a lateral side of the first prong and a longitudinal axis of the hollow needle is at least about 20 degrees, 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 the angle between a lateral side of the first prong and a longitudinal axis of the hollow needle to be at least 20 degrees as applicant appears to have placed no criticality on the claimed range (see Specification [0248] indicating the angle “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 31, the combination of Austen and Carrison discloses the invention of claim 30, Austen further discloses wherein the at least one hollow needle comprises a second prong at the distal end of the hollow needle (see Fig. 5B).
Regarding claim 32, the combination of Austen and Carrison discloses the invention of claim 21, Austen further discloses wherein the first prong and/or the second prong comprises a flat tip (since the Specification defines a “flat tip” as either perpendicular to the longitudinal axis or at an angle relative thereto (see Spec. Para. [0254), Fig. 5A-5B show wherein the tips of the needle are at angles relative to the longitudinal axis and therefore are seen to read on the claimed limitation in light of the definition provided within the specification).
Regarding claim 33, the combination of Austen and Carrison discloses the invention of claim 31, Austen further discloses wherein the first prong and/or the second prong comprises an edge (see Fig. 5B, see also Para. [0067]).
Regarding claim 34, the combination of Austen and Carrison discloses the invention of claim 1, Austen further discloses wherein an inner diameter of the at least one hollow needle is between about 0.14 mm and 0.84 mm (see Abstract, Claims 4-6 and Para. [0048]-[0049] and [0076]).
Regarding claim 35, the combination of Austen and Carrison discloses the invention of claim 1, Austen further discloses wherein an inner diameter of the at least one hollow needle is between about 0.24 mm and 0.40 mm (needles of Austen can be formed, e.g., from a conventional syringe needle or an equivalent tube having a size between 18 and 30 gauge, which corresponds to approximately the internal diameters and hole sizes between about 0.84mm and 0.14mm, see Abstract and Para. [0048]-[0049] and [0076]).
Regarding claim 36, the combination of Austen and Carrison disclose the invention of claim 1, Austen further discloses wherein the at least one hollow needle is configured to extend (i) into a dermal layer, (ii) through the entire dermal layer to a junction of the dermal layer and a subcutaneous fat layer, or (iii) into the subcutaneous fat layer (in skin tissue, such coring needle protrusion lengths can facilitate the formation of holes that extend substantially through the entire thickness of the dermal layer without penetrating significantly into the underlying subcutaneous fat layer, see Para. [0054]).
Regarding claim 38, the combination of Austen and Carrison discloses the invention of claim 1, Austen further discloses wherein the portion of the skin tissue is a microcore (see Para. [0012], [0016] and [0048]-[0050]).
Regarding claim 39, the combination of Austen and Carrison discloses the invention of claim 6, Austen further discloses wherein the needle hub comprises a two-by-two array of needles (see Para. [0011], [0017], [0045], [0063], and [0081]-[0082] mentioning wherein any number of arrangement of needles would be an obvious variant of the disclosed invention).
Regarding claim 43, the combination of Austen and Carrison discloses the invention of claim 23, Austen further discloses wherein the removal system comprises a vacuum pump (see Para. [0071]).
Regarding claim 44, Austen discloses:
An apparatus (apparatus 400, see Fig. 4A) for producing a cosmetic effect in skin tissue, the apparatus comprising:
(i) a needle hub (substrate 130, see Fig. 4B, see also Para. [0014]) comprising at least one hollow needle (needle 120, see Fig. 4A/4B) having a distal end for contacting skin and configured to remove a portion of the skin tissue when the hollow needle is inserted into and withdrawn from the skin tissue (see Abstract, Para. [0002]-[0020] and Figs. 4-5), the needle hub comprising:
a first lumen ((lumen of needle (120)) having a first end (distal-most portion) and a second end (proximal-most portion), wherein the first lumen comprises a lumen of the at least one hollow needle (end of lumen 120, see Fig. 6), and wherein the first end of the first lumen is at the distal end of the hollow needle (see Fig. 6); and
a second lumen (lumen of conduit 620, see Fig. 6) having a wall (external walls of the conduit 620, see Fig. 6), a first end (distal-most portion), and a second end (proximal-most portion), wherein the first lumen is connected to the second lumen such that the second end of the first lumen forms an opening in the wall of the second lumen (proximal end of needle (120) forms a manifold in conduit (620), see Para. [0071]-[0074], see also Fig. 6), and wherein the second end of the second lumen is connected to a fluid conduit such that when low pressure or vacuum is applied to the conduit, low pressure or vacuum is induced in the first lumen and the second lumen, such that fluid is drawn into and through the second lumen through the first end of the second lumen, thereby clearing skin tissue from the first lumen (see Para. [0071] mentioning wherein a conduit (620) is connectable to a source of low pressure (not shown) that would transmit through the conduit, through the first and second lumen to the distal tip of the needles adhere them the skin), the apparatus further comprising:
(ii) a translation and/or actuation mechanism (reciprocating arrangement 420, see Fig. 4A/4B) connected to the needle hub (see Figs. 4A/4B) to translate and/or actuate the needle hub in one or more directions relative to a surface of the skin tissue (see Figs. 4A-4B, see also Para. [0058]); and
(iii) a spacer (distal end of 400, see Examiner’s Diagram of Austen Fig. 4A below) to stabilize and/or maintain a constant position of the apparatus relative to the surface of the skin tissue (spacing of holes (220) in tissue can be determined, e.g., by reciprocating frequency and/or translational speed of the apparatus (400) over tissue surface. Fig. 4A shows distal end of (400) maintains distance to the skin surface, see also Para. [0014]); wherein the spacer includes:
a frame (exterior structural frame of the “Spacer Portion” as designate in Examiner’s Diagram of Fig. 4A below) to contact the surface of the skin tissue (see Para. [0014] mentioning wherein the housing (400) is configured to contact, stretch and/or stabilize tissue when placed thereon);
wherein the frame comprises a base (bottom-most portion of the housing that contacts tissue, see Examiner’s Diagram of Fig. 4A below), an inner wall (radially-inward wall of the “Spacer Portion” facing “substrate 130” as shown in Examiner’s Diagram of Fig. 4A below) and an outer wall (radially-outward wall of the “Spacer Portion” facing the exterior environment as shown in Examiner’s Diagram of Fig. 4A below).
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Examiner’s Diagram of Fig. 4A
However, Austen does not expressly disclose:
wherein the spacer includes a channel within which a vacuum source is applied to the skin tissue;
wherein the spacer further includes a vacuum spacer;
wherein the base, the inner wall and the outer wall form a channel in the frame;
wherein the channel is configured such that when the frame is placed on the surface of the skin, the surface of the skin, the base, the inner wall and the outer wall form a frame lumen; and
wherein the frame is connected to a fluid conduit such that when low pressure or vacuum is applied to the fluid conduit, low pressure or vacuum is established in the frame lumen, thereby drawings skin tissue toward and/or into the channel.
In an analogous field of endeavor, namely tissue-treatment devices configured to be adhered to and/or in direct contact with tissue, Carrison discloses a tissue treatment device (treatment device 700, see Figs. 7A-7E) comprising tissue-contacting vacuum spacer (spacer 704 and anchor 706 which are connected together and define a “Spacer” structure, see Figs. 7A-7E and Para. [0082]-[0084]) comprising a base (distal-most portion of anchor 706, see Examiner’s Diagram of Carrison Fig. 7A below), an inner wall (radially-inward wall portion of the spacer (704) facing the vacuum lumen 712/722, see Examiner’s Diagram of Carrison Fig. 7A below) and an outer wall (radially-outward portion of the spacer facing exterior of the device as shown in Examiner’s Diagram of Carrison Fig. 7A below) which form a channel within the “Spacer” (vacuum lumen 712 and spacer lumen 722, see Fig. 7A); wherein the channel is configured such that when the frame is placed on the surface of the skin, the surface of the skin, the base, the inner wall and the outer wall form a frame lumen (vacuum lumen 712/spacer lumen 722 and vacuum openings 724, see Fig. 7A and Para. [0082]-[0084]); and
wherein the frame is connected to a fluid conduit such that when low pressure or vacuum is applied to the fluid conduit, low pressure or vacuum is established in the frame lumen (vacuum tubing 752, see Fig. 7D and Para. [0084]), thereby drawings skin tissue toward and/or into the channel (see Para. [0082]-[0084]).
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Examiner’s Diagram of Carrison Fig. 7A
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 the “Spacer Portion” of the apparatus (400) of Austen to comprise a vacuum channel/lumen extending therethrough, between the “inner wall” and “outer wall” and terminating at one or more vacuum openings within the “base” as taught and suggested by Carrison to, in this case, allow a user to apply a vacuum through the frame of the housing to the tissue-contacting surface of the “base” which would aid in securing the device to the skin via the applied suction force (see Carrison Para. [0082]-[0084]).
Regarding claim 45, the combination of Austen and Carrison discloses the invention of claim 44, Austen further discloses wherein each of the first lumen and the second lumen are substantially straight (see Fig. 6), and wherein the first lumen is substantially perpendicular to the second lumen forming a T-junction (see Fig. 6).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austen (WO 2012/103492 A1)(previously of record) in view of Carrison (US 2018/0236146 A1)(previously of record), further in view of Schomacker (US 2012/0158100)(previously of record).
Regarding claim 11, the combination of Austen and Carrison disclose all of the limitations of the invention of claim 8.
However, none of either Austen of Carrison expressly discloses wherein the fluid intake nozzle is a convergent nozzle.
However, in the same field of endeavor, namely surgical skin treatment devices comprising needles, Schomacker teaches wherein a fluid intake nozzle (22) is a convergent nozzle (see Fig. 1).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)), to have obtained predictable result of having the nozzle of Austen having a narrowing, convergent nozzle as disclosed to be known in the art by the teachings of Schomacker. Since Austen discloses a reciprocating needle array with a conduit connectable for suction (see Abstract, Para. [0015] and [0071]-[0074] and Fig. 6) and Schomacker also discloses a reciprocating needle array with a conduit that has a nozzle that narrows, connectable for suction (see Abstract, Para. [0002], [0004]-[0014] and [0035]-[0038] and Fig. 1), one of ordinary skill in the art would have had a reasonable expectation of success that such a modification would yield to predictable results since Austen does not disclose any particular criticality pertaining to the disclosed nozzle shape, therefore not infringing on any particular benefit when making such a modification.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austen (WO 2012/103492 A1)(previously of record) in view of Carrison (US 2018/0236146 A1)(previously of record), further in view of Eppstein (US 5885211 A)(previously of record).
Regarding claim 14, the combination of Austen and Carrison disclose all of the limitations of the invention of claim 13.
However, none of either Austen or Carrison expressly discloses wherein the actuator is or comprises a voice coil.
However, in the same field of endeavor, namely surgical skin treatment devices comprising needles, Eppstein teaches wherein a needle actuator is or comprises a voice-coil mechanism, a simple solenoid, a rotary system with a cam or bell-crank, and the like (see Col. 19, Lines 28-50 and Fig. 7).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)), to have obtained predictable result of having the actuation system of Austen comprise a voice-coil mechanism as disclosed by Eppstein. Since Austen already discloses wherein the actuation mechanism comprises a rotary system with a cam or bell-crank (see Para. [0014], [0058] and [0062]-[0062] and Figs. 3-6), one of ordinary skill in the art would have expected the actuation mechanism to operate equally well either a cam or bell-crank or a voice-coil actuator system since Eppstein expressly discloses wherein these systems are interchangeable with one-another.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austen (WO 2012/103492 A1)(previously of record) in view of Carrison (US 2018/0236146 A1), further in view of Bodduluri (US 2007/0106306 A1)(previously of record).
Regarding claim 15, the combination of Austen and Carrison discloses all of the limitations of the invention of claim 13.
However, Austen does not expressly disclose a sensing device for detecting a position of the needle hub along the z-axis.
However, in the same field of endeavor, namely surgical systems for operations on or within the skin, Bodduluri teaches comprising a sensing device for detecting a position of the needle hub along the z-axis (see Abstract) to allow for visual detection and control of the needle array position along an x, y, and z axis (see Para. [0051], [0115] and Figs. 1-19).
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 the sensor of Austen to incorporate the sensor and controller as taught and suggested by Bodduluri to, in this case, allow for visual detection and control of the needle array in positions along an x, y, and z axes (see Bodduluri Para. [0051], [0115] and Figs. 1-19).
Regarding claim 16, the combination of Austen and Carrison disclose all of the limitations of the invention of claim 1.
However, none of either Austen or Carrison expressly disclose wherein the translation and/or actuation mechanism comprises an x/y-stage to translate the needle hub in one or more directions parallel to the surface of the skin.
However, in the same field of endeavor, namely surgical systems for operations on or within the skin, Bodduluri teaches wherein a translation and/or actuation mechanism comprises an x/y-stage (see Fig. 1) to translate a needle hub (30) in one or more directions parallel to the surface of the skin (arm 27 provides precisely controller movement of a distal end plate (not seen in Fig. 1) in six degrees of freedom (x, y, z, omega, rho, r) as is well known in the art (see Para. [0004]-[0011], [0046] and [0051]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have incorporated the actuation mechanism and controller of Bodduluri to, in this case, provide precisely controller movement of a distal end piece (not seen in Fig. 1) in six degrees of freedom (x, y, z, omega, rho, r) as is well known in the art (see Bodduluri Para. [0004]-[0011], [0046] and [0051]).
Claim(s) 23 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austen (WO 2012/103492 A1)(previously of record) in view of Carrison (US 2018/0236146 A1)(previously of record), further in view of Freeman (US 2004/0186421 A1)(previously of record).
Regarding claim 23, the combination of Austen and Carrison disclose all of the limitations of the invention of claim 1.
However, none of either Austen or Carrison expressly discloses wherein the frame is contoured.
However, in the relevant field of endeavor of surgical vacuum devices, Freeman discloses wherein a tissue-contacting frame (114, see Fig. 10) is contoured (see Fig. 10) to allow for a complete seal against the surface of the skin to create a sealed treatment zone such that the applicator physically conforms to a non-smooth skin surface of the subject (see Para. [0084] and [0146] and Fig. 10).
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 the frame of the “Spacer” of Austen to comprise a contoured surface, as taught and suggested by Freeman to, in this case, allow for a complete seal against the surface of the skin to create a sealed treatment zone such that the applicator physically conforms to a non-smooth skin surface of the subject (see Freeman Para. [0084] and [0146] and Fig. 10).
Regarding claim 42, the combination of Austen, Carrison and Freeman discloses the invention of claim 23, Austen, as modified by Freeman, further discloses wherein the frame is concave (see Freeman Fig. 10 showing wherein the contoured frame, as incorporated into the device of Austen, is concave).
Claim(s) 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austen (WO 2012/103492 A1)(previously of record) in view of Carrison (US 2018/0236146 A1)(previously of record), further in view of Yeshurun (US 2009/0048557 A1)(previously of record).
Regarding claim 24, the combination of Austen and Carrison disclose all of the limitations of the invention of claim 1.
However, none of either Austen or Carrison expressly discloses wherein the spacer comprises a switch connected to a sensor to detect a position of the apparatus relative to tissue underlying the skin, wherein:
(a) when the frame is placed on the surface of the skin and a low pressure or vacuum is applied to the frame, the switch is in a treatment inhibited position, and
(b) when the frame, while the frame is in contact with the surface of the skin after a low pressure or vacuum is applied to the frame, and after the frame is moved in a direction that is substantially perpendicular to and away from the surface of the skin, the switch is in a treatment enabled position;
wherein, when the switch is in the treatment inhibited position, the needle hub is prevented from moving along a z-axis in a direction substantially perpendicular to a surface of the skin tissue and substantially parallel to a longitudinal axis of the at least one hollow needle; and wherein, when the switch is in the treatment enabled position, the needle hub is moveable along the z-axis.
However, in the same field of endeavor, namely surgical skin treatment devices comprising needles, Yeshurun teaches:
wherein a spacer comprises a switch (switch arrangement 124) connected to a sensor (see Fig. 2) to detect a position of the apparatus relative to tissue underlying the skin (pressure from skin applied to rod (124) pushes it off sensor when pressure is above a given limit to interrupt operation, see Abstract, Para. [0003], [0042], and [0091]-[0092]), wherein:
(a) when the frame (distal end) is placed on the surface of the skin and a low pressure or vacuum is applied to the frame, the switch is in a treatment inhibited position (a pressure-limiting switch arrangement associated with the skin interface element and responsive to contact pressure of the skin interface element above a given limit to interrupt operation of the vibration generating mechanism, see Abstract, Para. [0003], [0042], and [0091]-[0092]), and
(b) when the frame (distal end), while the frame (distal end) is in contact with the surface of the skin after a low pressure or vacuum is applied to the frame (vacuum of Austen), and after the frame is moved in a direction that is substantially perpendicular to and away from the surface of the skin, the switch (switch arrangement 124) is in a treatment enabled position (when pressure is not applies to distal end the switch is enabled, see Abstract, Para. [0003], [0042], and [0091]-[0092]);
wherein, when the switch (switch arrangement 124) is in the treatment inhibited position (pressure applied), the needle hub (104) is prevented from moving along a z-axis in a direction substantially perpendicular to a surface of the skin tissue and substantially parallel to a longitudinal axis of the at least one hollow needle (micro-projections or microneedles) (here is also provided a pressure- limiting switch arrangement associated with the skin interface element and responsive to contact pressure of the skin interface element above a given limit to interrupt operation of the vibration generating mechanism, see Para [0031]); and
wherein, when the switch (124) is in the go treatment enabled position, the needle hub is moveable along the z-axis (does not interrupt vibration generating mechanism) (see Abstract, Para. [0003], [0042], and [0091]-[0092]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have distal end of the device of Austen incorporate the switch and sensor of Yeshurun. Doing so would allow for a safety mechanism to interrupt the actuation mechanism (see Yeshurun Abstract, Para. [0003], [0031], [0042], [0076], and [0091]-[0092]).
Regarding claim 25, the combination of Austen, Carrison and Yeshurun disclose the invention of claim 24, Austen, as modified by Carrison, further disclose wherein the sensor is or comprises a pushrod (see Yeshurun Fig. 2 showing arrangement (124) as a rod that is pushed off a circuit, see Yeshurun Abstract, Para. [0003], [0042], and [0091]-[0092]).
Claim(s) 40-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austen (WO 2012/103492 A1)(previously of record) in view of Carrison (US 2018/0236146 A1)(previously of record), further in view of Gurtner (US 2012/0226214 A1)(previously of record)
Regarding claim 40, the combination of Austen and Carrison discloses all of the limitations of the invention of claim 6, Austen further discloses wherein the needle array comprises one or more needles which may be arranged in and size, shape, spatial arrangement and geometry (see Para. [0011], [0017], [0045], [0063], and [0081]-[0082] mentioning wherein any number of arrangement of needles would be an obvious variant of the disclosed invention).
However, Austen does not expressly show or disclose wherein the needle hub comprises a three-by-two array of needles.
However, in the same field of endeavor, namely surgical needling devices for therapeutic or cosmetic effect, Gurtner teaches wherein a needle hub (190) comprises a three-by-two array of needles (see Fig. 13D showing an array designed for a 3x2 configuration).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element/arrangement for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of wherein the device of Austen comprise a 3-by-2 arrangement of needles within the substrate as disclosed by Gurtner. Since Austen discloses wherein any arrangement of needles up to a 5x4 array may be possible, one of ordinary skill in the art would have expected the device of Austen to function equally well with a 3x2 arrangement as disclosed by Gurtner since this known configuration is within the allowed scope as defined by Austen. Further, this claimed arrangement is not seen to be critical to the function of the device since the Specification discloses wherein different forms of dimensional arrays recited which are thus seen to be non-limiting examples, see Para. [0288].
Regarding claim 41, the combination of Austen and Carrison disclose all of the limitations of the invention of claim 6, Austen further discloses wherein the needle array comprises one or more needles which may be arranged in and size, shape, spatial arrangement and geometry (see Para. [0011], [0017], [0045], [0063], and [0081]-[0082]).
However, Austen does not expressly show or disclose wherein the needle hub comprises a three-by-three array of needles.
However, in the same field of endeavor, namely surgical needling devices for therapeutic or cosmetic effect, Gurtner teaches wherein a needle hub (190) comprises a three-by-three array of needles (see Fig. 3A and 15A showing an array designed for a 3x3 configuration).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element/arrangement for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of wherein the device of Austen comprise a 3-by-3 arrangement of needles within the substrate as disclosed by Gurtner. Since Austen discloses wherein any arrange of needles up to a 5x4 array may be possible, one of ordinary skill in the art would have expected the device of Austen to function equally well with a 3x3 arrangement as disclosed by Gurtner since this known configuration is within the allowed scope as defined by Austen. Further, this claimed arrangement is not seen to be critical to the function of the device since the Specification discloses wherein different forms of dimensional arrays recited which are thus seen to be non-limiting examples, see Para. [0288].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 11185672 B2 to Tharp, US 11298529 B2 to An, US 12208047 B2 to Anderson, US 12329435 B2 to Varshavsky, US 10638963 B2 to Beyerlein, US 10220195 B2 to O’Brien, US 11896261 B2 to Ginggen, US 2014/0163536 A1 to Clark and US 2012/0158100 A1 to Schomacker all disclose tissue treatment devices configured to puncture the skin comprising a hollow needle.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771