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 .
Response to Amendment
The amendment filed 06/08/2026 has been entered, claims 1-8, 12, 13, 17, 18, 20 remain pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites “a base of adjacent pyramids of the head portions are spaced about 2mm apart”. However, claim 13 is dependent on Claim 1, claim 1 recites “the square bases of adjacent pyramids abut one another”. It is unclear how the bases can be spaced apart when the bases are abut one another. Therefore, Claim 13 is indefinite.
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) 1-8, 12, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsushita (US20140288473), in view of Tankovich (US10973757).
Regarding Claim 1, Matsushita discloses a skin stimulation tool to increase penetration and efficacy of topically applied products and medications (Fig. A, annotated below; par. 0022, beauty instrument 10), the skin stimulation tool comprising: a substantially Y-shaped handle (Fig. A, annotated below; par. 0022, handle 11); a first attachment on a first branch of the Y-shaped handle (Fig. A, annotated below; par.0022 bifurcated portions 11a), and a second attachment on a second branch of the Y-shaped handle (Fig. A, annotated below; par. 0022 bifurcated portions 11a); a first head portion mounted to rotate around the first attachment of the handle, and a second head portion independently mounted from the first head portion to rotate around the second attachment of the handle (Fig. A, annotated below; par. 0024, balls 17, “Then, the balls 17 are rotated about the ball supporting shafts 15.”), both of the head portions rotating when applied to a surface of the skin under linear motion of the handle (par 0035, “when the balls 17 are moved forward… each of the balls 17 is rotate…”);
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Fig. A: Adapted from Matsushita Fig. 1
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Fig. B, Adapted from Matsushita Fig. 7
Matsushita is silent on a plurality of distinct pyramids formed on each of the first and second head portions, each of the distinct pyramids having a pointed top portion the size of a needle and four sides progressively widening toward a square base, and each of the distinct pyramids having a height in a range of about 0.5 mm to about 0.7 mm to form a micro-passage in the skin at a depth that only passes through the stratum corneum, and limits the impact on more sensitive skin layers; wherein the square bases of adjacent distinct pyramids abut one another, covering substantially the entire surface of each of the first and second head portions; wherein the shape and dense arrangement of the pyramids is configured to form a number of micro-channels in the skin when the pyramids are in contact with the skin during use to open skin pores and form pathways into the skin by the pyramids rolling over the skin, thereby increasing penetration of a topical agent as the pointed top portion of each of the pyramids are pressed deeper into the skin, wherein the raised surface works at a lipid-corneocyte surface of the skin to temporarily separate stratum corneum layers to create pathways into the skin without causing long term structural damage to the skin.
However, Tankovich discloses a needling device (Fig. 1, Abstract), comprising of a surface (Fig. 1, cap film 25), a plurality of distinct pyramids (col. 6 line 31-34, “it should be understood that the MNs structure may be provided in any suitable shape or combination of shapes, e.g., pyramids, hemispherical protrusions, walls”), each of the distinct pyramids having a pointed top portion the size of a needle (Fig. 1, col. 6 line 18-22, the pyramids are microneedles and therefore has a size of a needle) and four sides progressively widening toward a square base (col. 6 line 31-34, an pyramid under ordinary definition has the claimed geometry, see Fig. 1), and each of the distinct pyramids having a height in a range of about 0.5 mm to about 0.7 mm (col. 10 line 26-27, “MNs which are pyramidal or conical in shape, 600 μm long”; 600 μm is 0.6 mm which is within the claimed range) to form a micro-passage in the skin at a depth that only passes through the stratum corneum, and limits the impact on more sensitive skin layers (col. 6 line 9-11, “a length of the microneedle penetrates the film and the stratum corneum of the epidermis of the skin”); wherein the square bases of adjacent distinct pyramids abut one another, covering substantially the entire surface (See Fig. 1, the base of each protrusion abut one another). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known skin stimulation tool of Matsushita, with the needling device of Tankovich, and apply the pyramid surface to the first and second head portions of Matsushita, for penetrating skin layers to deliver topical skin treatments as taught by Tankovich (Tankovich, col. 12 line 54-61).
The modified Matsushita further discloses wherein the shape and dense arrangement of the pyramids is configured to form a number of micro-channels in the skin when the pyramids are in contact with the skin during use to open skin pores and form pathways into the skin by the pyramids rolling over the skin (Tankovich, col. 6 line 7-13, “upon applying the device to the skin with pressure (e.g. finger or thumb pressure) upon the cap film 25, a length of the microneedle penetrates the film and the stratum corneum of the epidermis of the skin…”), thereby increasing penetration of a topical agent as the pointed top portion of each of the pyramids are pressed deeper into the skin, wherein the raised surface works at a lipid-corneocyte surface of the skin to temporarily separate stratum corneum layers (Tankovich, col. 6 line 9-11, “a length of the microneedle penetrates the film and the stratum corneum of the epidermis of the skin”) to create pathways into the skin without causing long term structural damage to the skin (Tankovich, col. 12 line 57-61, “Microneedle devices suitable for use in the present invention may be used to deliver therapeutic agents or drugs (including any pharmacological agent or agents) through the skin in a variation on transdermal delivery, or to the skin for intradermal or topical treatment.”; the modified prior art has the claimed structure and therefore is capable of performing the claimed function, see MPEP 2114).
Regarding Claim 2, the modified Matsushita discloses the skin stimulation tool of claim 1, but is silent on the handle has a length of about 13 cm, and each branch of the Y-shaped handle having a length of about 3 cm.
Matsushita does not teach specifically the length of the handle and of each branch. However, the length of the handle is an obvious measurement for comfort of holding or being long enough for a user to roll. Matsushita does teach the diameter of the head portions, which are mounted on each branch of the Y-shaped handle. The diameter of the head portions are 20 mm (Matsushita, Example 16, Table 3) and 25 mm (Matsushita, Example 17, Table 3). The length of each branch of the Y-shaped handle is an obvious measurement, as each branch needs to be slightly longer than the diameter of the head portion for the head portion to mount and rotate. The diameter from the prior art (20 mm, 25 mm) and the claimed length of the branch (3 mm), are well within the anticipation range. There is also a lack of criticality as the applicant did not state the length of the handle and of each branch serve any particular purpose or solve any problem beyond what is commonly known in the arts (The applicant, par. 0030). The measurements in the claim are well within the purview of design choice, and is therefore prima facie obvious.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to give specific measurements to the handle and each branch of Matsushita for reasons noted above.
Regarding Claim 3, the modified Matsushita discloses the skin stimulation tool of claim 1, wherein the head portions are each about 25 mm wide and about 23 mm tall (Matsushita, Table 3, Diameter of ball; Example 17, 25 mm) (Examiner Notes: Because a portion of the ball is flat as shown in Fig. A and B, the height is shorter than the diameter; 25 mm is within 10% of 23 mm, therefore, the prior art overlaps with sufficient specificity and substantially identical to the claimed range; the claimed range is anticipated by the prior art. Note: examiner is construing the limitation “about” to be within plus and minus 10% of a recited dimension for all claims).
Regarding Claim 4, the modified Matsushita discloses the skin stimulation tool of claim 1, wherein the head portions are each about 10 mm to 25 mm wide and about 10 mm to 23 mm tall (Matsushita, Table 5: Diameter of ball; Example 30, 17 mm) (Examiner Notes: The prior art examples are within the claimed range; therefore, the claimed range is anticipated by the prior art).
Regarding Claim 5, the modified Matsushita teaches the skin stimulation tool of claim 1, but is silent on a distance between a top-most portion of each of the head portions and an end portion of the handle is about 169 mm.
Matsushita does not specifically teach the distance between a top-most portion of each of the head portions and an end portion of the handle. However, the distance is simply a measurement of the total length of the invention, the distance itself is not inventive and can be easily estimated by adding the length of the handle, the diameter of the head portion, and the thickness of the surface of the head portion. By adding a dimension, it would not affect the performance of the invention and would not be patently distinct from the prior art. There is also a lack of criticality as the applicant did not state the distance between a top-most portion of each of the head portions and an end portion of the handle serves any particular purpose or solve any problem beyond what is commonly known in the arts (The applicant, par. 0030). The measurements in the claim are well within the purview of design choice, and is therefore prima facie obvious.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to measure and dimension the device of Matsushita for reasons noted above.
Regarding Claim 6, the modified Matsushita discloses the skin stimulation tool of claim 1, wherein a distance between an outermost surface of each of the first head portion and the second head portion is about 68 mm (Matsushita, Table 3: Diameter of the ball; Example 18, 27.5 mm; par. 0059, distance between balls, 11 mm) (Examiner Notes: The claimed distance can be estimated by adding two of the diameters of the ball, and the distance between balls, which comes out to be 66 mm. The distance of 66 mm is within 10% of 68 mm, therefore, the distance has sufficient specificity and the claimed distance is anticipated by the prior art).
Regarding Claim 7, the modified Matsushita teaches the skin stimulation tool of claim 1, but is silent on a distance between an inner most surface of each of the head portions and a back of the handle is about 33 mm.
Matsushita does not specifically teach the distance between an inner most surface of each of the head portions and a back of the handle. However, the distance is simply a measurement of the thickness of the invention, the distance itself is not inventive and can be easily estimated by the diameter of the head portion and the thickness of the handle. By adding a dimension, it would not affect the performance of the invention and would not be patently distinct from the prior art. There is also a lack of criticality as the applicant did not state the distance between an inner most surface of each of the head portions and a back of the handle serves any particular purpose or solve any problem beyond what is commonly known in the arts (The applicant, par. 0030). The measurements in the claim are well within the purview of design choice, and is therefore prima facie obvious.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to measure and dimension the device of Matsushita for reasons noted above.
Regarding Claim 8, the modified Matsushita discloses the skin stimulation tool of claim 1, wherein the head portion is substantially spherical shaped (Matsushita, par. 0010, “…a spherical-shaped ball, the balls are partially in contact with the skin”).
Regarding Claim 12, the modified Matsushita discloses the skin stimulation tool of claim 1, wherein a base of adjacent pyramids of the head portions are in contact with one another (Tankovich, Fig. 1, the bases of the pyramids are in contact as shown in the figure).
Regarding Claim 17, the modified Matsushita discloses the skin stimulation tool of claim 9, wherein each of the plurality of pyramids formed on a surface of both head portions is substantially the same size (Tankovich, Fig. 1, each pyramid is the same size).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsushita, in view of Tankovich, further in view of Mcallister et al. (US10828478), hereafter Macallister.
Regarding Claim 13, the modified Matsushita discloses the skin stimulation tool of claim 1, but is silent on wherein a base of adjacent pyramids of the head portions are spaced about 2 mm apart.
However, Macallister teaches a microneedle array (Fig. 1), comprising of a plurality of protrusions (Fig. 1, microneedles 130), wherein a base of adjacent protrusions are spaced about 2 mm apart (col. 7 line 46-47, “The length of a microneedle (L.sub.MN) may be between about 50 μm and 2 mm”; col. 8 line 20-22, “each microneedle is separated from its nearest neighboring microneedle by a distance about equal to the height of the microneedle”; each needle can have a height of 2mm and are spaced from each other by a distance equal to the height.). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known tool of Matsushita, and space the base of adjacent pyramids of the head portions about 2mm apart, as applicant appears to have placed no criticality on the claimed range (See applicant’s specification, par. 0036) 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).
Claim(s) 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Matsushita, in view of Tankovich, further in view of Matsushita (US D668771), hereafter Mat’771.
Regarding Claim 18, the modified Matsushita discloses the skin stimulation tool of claim 1, but is silent on wherein the plurality of pyramids formed on both head portions increases in size from a middle surface toward an upper surface and toward a lower surface of both head portions
However, Mat’771 discloses a skin massaging roller (title) including two spherical head portions, with a plurality of polygons formed on the surface. The polygons are formed in such pattern that the polygons increase in size towards the middle of the sphere, and decrease in size toward the ends of the sphere (See Fig. C). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to form the pyramids in a specific pattern as claimed on both head portions as such is an art recognized suitable pattern for massaging or stimulating a user skin as exemplified in the disclosure of Mat’771.
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Fig. C, Adapted from Mat’771 Fig. 7
Regarding Claim 20, Matsushita discloses a skin stimulation tool to increase penetration and efficacy of topically applied products and medications (Fig. A; par. 0022, beauty instrument 10), the skin stimulation tool comprising: a substantially Y-shaped handle (Fig. A; par. 0022, handle 11); a first attachment on a first branch of the Y-shaped handle (Fig. A; par.0022 bifurcated portions 11a), and a second attachment on a second branch of the Y-shaped handle (Fig. A; par. 0022 bifurcated portions 11a); a first head portion mounted to rotate around the first attachment of the handle, and a second head portion independently mounted from the first head portion to rotate around the second attachment of the handle (Fig. A, ; par. 0024, balls 17, “Then, the balls 17 are rotated about the ball supporting shafts 15.”), both of the head portions rotating when applied to a surface of the skin under linear motion of the handle (par 0035, “when the balls 17 are moved forward… each of the balls 17 is rotate…”); and a raised surface on each of the first and second head portions (See Fig B, a cross-sectional view of the ball; par. 0025, “The outer surface of the shell material 28 is…”).
Matsushita is silent on a plurality of distinct pyramids formed on each of the first and second head portions, the raised surface opening skin pores to form pathways into the skin, thereby increasing penetration of a topical agent as the head portions are pressed deeper into the skin without causing long term structural damage to the skin; wherein the bases of adjacent distinct pyramids substantially abut one another, thereby covering substantially the entire surface of each of the first and second head portions; wherein the plurality of distinct pyramids vary in shape, increasing in size from a middle surface of each head portion, and toward an upper surface and a lower surface of both head portions, the distinct pyramids having a pointed top portion the size of a needle and four sides progressively widening toward a square base, and each of the distinct pyramids forming a micro-passage in the skin at a depth that only passes through the stratum corneum, and limits impact on more sensitive skin layers; and wherein the raised surface works at a lipid-corneocyte surface of the skin to temporarily separate stratum corneum layers to create pathways into the skin without causing long term structural damage to the skin.
However, Tankovich discloses a needling device (Fig. 1, Abstract), comprising of a surface (Fig. 1, cap film 25), a plurality of distinct pyramids (col. 6 line 31-34, “it should be understood that the MNs structure may be provided in any suitable shape or combination of shapes, e.g., pyramids, hemispherical protrusions, walls”), wherein the bases of adjacent distinct pyramids substantially abut one another, thereby covering substantially the entire surface (See Fig. 1, the base of each protrusion abut one another), each of the distinct pyramids having a pointed top portion the size of a needle (Fig. 1, col. 6 line 18-22, the pyramids are microneedles and therefore has a size of a needle) and four sides progressively widening toward a square base (col. 6 line 31-34, an pyramid under ordinary definition has the claimed geometry, see Fig. 1), and each of the distinct pyramids forming a micro-passage in the skin at a depth that only passes through the stratum corneum, and limits the impact on more sensitive skin layers (col. 6 line 9-11, “a length of the microneedle penetrates the film and the stratum corneum of the epidermis of the skin”). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known skin stimulation tool of Matsushita, with the needling device of Tankovich, and apply the pyramid surface to the first and second head portions of Matsushita, for penetrating skin layers to deliver topical skin treatments as taught by Tankovich (Tankovich, col. 12 line 54-61).
The modified Matsushita is still silent on wherein the plurality of distinct pyramids vary in shape, increasing in size from a middle surface of each head portion, and toward an upper surface and a lower surface of both head portions.
However, Mat’771 discloses a skin massaging roller (title) including two spherical head portions, with a plurality of polygons formed on the surface. The polygons are formed in such pattern that the polygons increase in size towards the middle of the sphere, and decrease in size toward the ends of the sphere (See Fig. C). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to form the pyramids in a specific pattern as claimed on both head portions as such is an art recognized suitable pattern for massaging or stimulating a user skin as exemplified in the disclosure of Mat’771.
The modified Matsushita further discloses the raised surface opening skin pores and form pathways into the skin by the pyramids rolling over the skin (Tankovich, col. 6 line 7-13, “upon applying the device to the skin with pressure (e.g. finger or thumb pressure) upon the cap film 25, a length of the microneedle penetrates the film and the stratum corneum of the epidermis of the skin…”), thereby increasing penetration of a topical agent as the pointed top portion of each of the pyramids are pressed deeper into the skin, wherein the raised surface works at a lipid-corneocyte surface of the skin to temporarily separate stratum corneum layers (Tankovich, col. 6 line 9-11, “a length of the microneedle penetrates the film and the stratum corneum of the epidermis of the skin”) to create pathways into the skin without causing long term structural damage to the skin (Tankovich, col. 12 line 57-61, “Microneedle devices suitable for use in the present invention may be used to deliver therapeutic agents or drugs (including any pharmacological agent or agents) through the skin in a variation on transdermal delivery, or to the skin for intradermal or topical treatment.”; the modified prior art has the claimed structure and therefore is capable of performing the claimed function, see MPEP 2114).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Tankovich teaches microneedles to penetrate the stratum corneum to form micro channels.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRIS HANYU GONG whose telephone number is (703)756-5898. The examiner can normally be reached M-F 8:30-4:30.
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/KRIS HANYU GONG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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