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
This office action is responsive to the amendment filed on December 21, 2025. As directed by the amendment: claims 1-9 have been amended, claims 10-12 have been cancelled, and no claims have been added. Thus, claims 1-9 and 13-24 are presently pending in this application. Applicant’s amendments are sufficient to overcome the claim objections and §112(b) rejections of the previous action.
Response to Arguments
Applicant's arguments filed December 21, 2025 have been fully considered but they are not persuasive.
On pages 8-9, Applicant argues that the structure of Chen 2014 is different than the structure of the invention. In response, Examiner notes that the relevant analysis is between the claims and Chen 2014, see below.
On page 9, Applicant argues that Chen 2014 teaches insertion of the patch or poultice into the skin during use, and the invention does not teach such use. In response, Examiner notes that the claims are directed to an apparatus, and not a method of use.
On page 9, Applicant speculates that during use, the cited references will experience issues related to depth of puncture. In response, Examiner notes that the claims are directed toward an apparatus, and not a method of use.
On page 9, Applicant speculates that during use, the support shaft of Chen 2014 my break off. In response, Examiner notes that the relevant question is whether or not Chen 2014 teaches the claimed invention.
On page 10 of the Remarks, Applicant argues that it would not be necessary to combine the needles of Chen 2012 with Hammond’s particles because Chen 2012 already teaches controlling the delivery rate of a drug. In response, see the rationale below describing advantages of LbL drug delivery taught by Hammond for controlling drug delivery of one or more agents, wherein the LbL particles of Hammond enable more precise control of drug delivery due to the structure of the particles.
On pages 10-11, Applicant argues the combination of Chen 2012 and Hammond citing differing drug release control times, and the use of heat (via near infrared light irradiation converted into heat) to dissolve the carrier material of Chen 2012. In response, Chen 2012 teaches that the use of heat controls the rate that the carrier material dissolves to control the release of drugs. However, once the drugs are released from the carrier, Hammond particles provide additional control of drug delivery via LbL particles.
On page 11, Applicant questions the use of heat in Chen 2012 to dissolve the carrier material, speculating on the damage such heat may cause to the skin. In response, Examiner notes that Fig. 17 teaches temperature rise of the patch, not the skin.
On pages 11-15, Applicant speculates on the modification to Chen 2012 in light of the manufacturing processes of Chen 2012, more specifically whether or not the Hammond particles can be combined with Chen 2012 given the manufacturing processes of Chen 2012. In response, Examiner notes that the Chen 2012 teaches encapsulated drugs, and Hammond teaches drugs. Additionally, P0141 of Hammond teaches stability of LbL microcapsules can be tuned for harsher environments with increased layer deposition.
Claim Objections
Claim 1 line 3 is objected to because of the following informalities: “needle” should be plural. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 4 line 2 recites “…the plurality of dissolving needles themselves are composed of…”. The written description does not support this, and instead uses the word “itself”. Claims 5-9 are similarly rejected and interpreted.
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.
Claims 4-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 4 line 2 recites “…the plurality of dissolving needles themselves are composed of…”. It is not clear if this limitation seeks to exclude the multi-layer granules of claim 1, especially since claim 4 includes encapsulated pharmaceuticals and cosmetics, and in light of P0012-0014 of the written description. For purposes of examination, claim 4 is interpreted to not exclude the multi-layer granules of claim 1. Claims 5-9 are similarly rejected and interpreted.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 7-8, 16-18 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Chen) US 2014/005606 A1 in view of Hammond et al. (Hammond) US 10,278,927 A1.
Regarding claim 1, Chen discloses an integumental dissolving needle device (Fig. 1) comprising: a patch or poultice (substrate 10, P0039) having a planar surface (planar surface, see annotated Fig. 1 below); a plurality of dissolving needle (biodegradable carrier 11, P0039) provided on the planar surface of the patch or poultice (see annotated Fig. 1 below); granules (drugs 12, P0039) housed by the plurality of dissolving needles, the granules being configured to contain one or more pharmaceuticals, or one or more cosmetics for delivery into delivered into skin, scales, bark, or other integumental tissue (Fig. 5), wherein the patch or poultice does not contain the multi-layer granules (Fig. 1).
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Chen does not teach the multi-layer granules comprising: a micronized particle of a first pharmaceutical or cosmetic, a coating agent layer that is to be absorbed into the integument, the coating agent layer encapsulating the micronized particle, a layer of either the first pharmaceutical or cosmetic, or a second pharmaceutical or cosmetic different from the first pharmaceutical or cosmetic, covering the coating agent layer, and an outer coating layer that is to be absorbed into the integument, the outer coating layer encapsulating the layer of either the first or second pharmaceutical or cosmetic.
However, Hammond teaches multi-layer granules for systemic administration (layer-by-layer (LbL) coated particles, as shown in Fig. 1, that can comprise various numbers of layers, c 13 ln 57 to c 14 ln 8) comprising: a micronized particle of a first pharmaceutical (col. 21, lines 38-44 describes the nanoparticle core being made hollow to compartmentalize biologics or a reservoir of drugs; col. 15, line 65-col. 16, line 5 describes various drugs and compositions that could be incorporated in the LbL films) or cosmetic (col. 16, lines 3-5 describes nutraceutical agents such as vitamins and minerals; lines 52-53 describes anti-microbials; U.S. Patent Application Publication 2002/0160965 to Lanzendorfer et al. para. 178 describes additives customary in cosmetics include vitamins and anti-microbials), a coating agent layer (Fig. 1, LbL nanofilms; col. 13, lines 45-46 describes the first layer as coating the core) that is to be absorbed into the integument (col. 15, lines 20-26 describes the layers being formed of degradable polyelectrolyte that degrades when exposed to a liquid medium such as intracellular fluid, interstitial fluid that would be present in the integument, thus the layer as it degrades is absorbed into the integument), the coating agent layer encapsulating the micronized particle (col. 13, line 45-46 describes the first layer as coating, i.e. encapsulating, the core; see also Fig. 1), a layer (Fig. 1, LbL nanofilms) of either the first pharmaceutical or cosmetic, or a second pharmaceutical or cosmetic different from the first pharmaceutical or cosmetic (col. 15, lines 26-28 describes the LbL layer degradation gradually and controllably releases releasable agents; col. 15, line 65-col. 16, line 5 describes various drugs and compositions that could be incorporated in the LbL films; and col. 16, lines 3-5 describes release agents such as vitamins and minerals; lines 52-53 describes anti-microbials, both of which are used in cosmetics), covering the coating agent layer (Fig. 1; col. 13, lines 41-56), and an outer coating layer (col. 13, lines 46-47 describes an outer layer forming the particle surface) that is to be absorbed into the integument (col. 15, lines 20-26 describes the layers being formed of degradable polyelectrolyte that degrades when exposed to a liquid medium such as intracellular fluid, interstitial fluid that would be present in the integument, thus the layer as it degrades is absorbed into the integument), the outer coating layer encapsulating the layer of either the first or second pharmaceutical or cosmetic (col. 13, lines 46-47 describes an outer layer forming the particle surface thus encapsulating the layer of either the first or second pharmaceutical or cosmetic layer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the LbL coated particles of Hammond within the biodegradable carriers of Chen for the purpose of delivering a rich diversity of therapeutic or other agents, col. 1, lines 29-35, and further to manipulate the in-vivo stability, biodistribution, targeting and/or controlled release of one or more agents, as taught by Hammond col. 8, lines 55-58.
Regarding claims 2 and 3, Chen in view of Hammond teaches the integumental dissolving needle device according to Claim 1, further comprising: additional granules housed by the plurality of dissolving needles (Chen, Figs. 1-2 and 5 show multiple additional granules incorporated into the microneedles), the additional granules comprising: a/another (a/another are interpreted as synonyms) micronized particle of the first pharmaceutical or cosmetic (as taught by Hammond, see claim 1 above), and an/another (a/another interpreted as synonyms) outer coating layer that is to be absorbed into the integument, the outer coating layer encapsulating the micronized particle (as taught by Hammond, see claim 1 above).
Regarding claims 4-5 and 7-8, Chen in view of Hammond teaches the integumental dissolving needle device according to Claims 1 and 2, wherein Chen further teaches the plurality of dissolving needles themselves are composed of one of: one or more pharmaceuticals (Chen, the biodegradable carrier 11 encapsulates drugs 12).
Regarding claims 16-18, Chen in view of Hammond teaches the integumental dissolving needle according to Claims 1, 2 and 4, but does not explicitly teach the multi-layer granules further include a structure in which (1) the layer of either the first or second pharmaceutical or cosmetic, and (2) the outer coating layer that is absorbed into the integument are all repeated.
Hammond teaches the LbL coated particles can comprise various numbers of layers, c 13 ln 57 to c 14 ln 8, up to 100. Additionally, Hammond teaches controlled release of one or more agents, c 8 ln 54-59, and that releasing of agents associated with LbL films can be fine-tuned, so that dose and kinetics of releasing agents may vary depending on film design and construction, c 18 ln 50-54.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to apply a known technique to a known product ready for improvement to yield predictable results, MPEP 2143(I)(D). Hammond contained a “base” product, LbL particles, upon which the claimed invention can be seen as an “improvement”, which is repeating layers. Hammond contained a known technique that is applicable to the base device, the technique of adding layers and the use of layers for controlled release of one (or more) agents, c 8 ln 54-59. One of ordinary skill in the art would have recognized that applying the known technique would have yielded predictable results of controlled release and resulted in an improved system for delivering agents.
Regarding claim 21-24, Chen in view of Hammond teaches the integumental dissolving needle device according to Claims 1, 2, 4 and 17.
Chen in view of Hammond do not teach wherein the coating agent is phosphate ester or phospholipids, Hyaluronic acid, trehalose, sucrose, gelatin, collagen, keratin or dextran.
However, Applicant has not indicated the claimed coating as being critical. Applicant’s P0022 describes various compositions that may be used, the critical factor being biocompatibility. The last sentence of Applicant’s P0022 recites that any biocompatible substance capable of encapsulating the pharmaceutical or cosmetic ingredients and being absorbed in the integument may be used, which includes the coatings taught by Hammond which are biocompatible. Utilizing the claimed coating will not adversely affect the coating agent of Hammond since Hammond teaches using other coatings listed in Applicant’s P0022 including biodegradable polymers, Hammond c 15 ln 43. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the coating agents of Hammond to include phosphate ester or phospholipids as claimed because it appears to an arbitrary choice which fails to patentably distinguish over Hammond.
Alternatively, claims 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Hammond and further in view of Ozel et al. (Ozel) US 2013/0096532 A1.
Regarding claim 21-24, Chen in view of Hammond teaches the integumental dissolving needle device according to Claims 1, 2, 4 and 17.
Chen in view of Hammond does not teach wherein the coating agent is phosphate ester or phospholipids, Hyaluronic acid, trehalose, sucrose, gelatin, collagen, keratin or dextran.
However, Ozel teaches a microneedle array that utilizes phospholipid encapsulated microbubbles, P0077.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the coating agent of Hammond with a phospholipid as taught by Ozel for the purpose of delivering bioactive agents, Ozel P0077.
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Hammond in view of Jung et al. (Jung) US 2011/0177139 A1.
Regarding claims 6 and 9, Chen in view of Hammond teaches the integumental dissolving needle device according to Claims 1 and 2.
Chen does not teach the plurality of dissolving needles themselves are composed of one or more cosmetics.
However, Jung teaches a microstructure wherein the plurality of dissolving needles themselves are composed of one or more cosmetics (cosmetic ingredients, P0049).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the drugs of Chen 695’ to include cosmetics for the purpose of treating wrinkles, inhibiting skin aging or to whiten skin, Jung P0049.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Hammond in view of Jung and further in view of Clay et al. (Clay) US 2016/0022975 A1.
Regarding claims 13-15, Chen in view of Hammond teaches the integumental dissolving needle device according to Claims 1, 2 and 4.
Chen in view of Hammond does not teach wherein: the integumental dissolving needle device is sectionable.
However, Jung teaches a microstructures wherein the integumental dissolving needle device is sectionable (Figs. 6a, 7a, 8a, 9a, 10a; para. 59 shows the substrate or needles can be separated, i.e. sectionable, from the substrate or into smaller sizes and lengths such as by physically cutting the needles with a knife or using a laser cutter).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the dissolving needle device of Chen in view of Hammond to be sectionable as taught by Jung for the purpose of delivering an appropriate dosage.
Chen in view of Hammond in view of Jung does not teach a product name or product names and dosage or dosages written on a surface or surfaces of the integumental dissolving needle device.
Clay teaches a product name or product names and dosage or dosages written on a surface or surfaces of the [device] (Figs. 8d, 8e; para. 106 describes the drug name and dosage appearing on the surface of a ring attached to the device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included Clay’s labeling with a product name or product names and dosage or dosages written on a surface or surfaces of the integumental dissolving needle device of Chen in view of Hammond in view of Jung “to facilitate selection of a drug delivery device containing the correct drug” (para. 67) as taught by Clay.
Alternatively, and for the purpose of rejecting claims 19-20, the following rejections are made in view of Chen 695’.
Claims 1-5, 7-8 and 16-24 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Chen 695’) US 2012/0283695 A1 in view of Hammond.
Regarding claim 1, Chen 695’ discloses an integumental dissolving needle device (Fig. 1) comprising: a patch or poultice (substrate 11, P0039) having a planar surface (see annotated Fig. 1 below); a plurality of dissolving needle (biodegradable carrier 12, P0042) provided on the planar surface of the patch or poultice (see annotated Fig. 1 below); granules (drugs 13, P0042) housed by the plurality of dissolving needles the multi-layer granules being configured to contain one or more pharmaceuticals, or one or more cosmetics, for delivery into skin, scales, bark, or other integumental tissue (Fig. 10), wherein the patch or poultice does not contain the multi-layer granules (Fig. 1).
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Chen 695’ does not teach the multi-layer granules comprising: a micronized particle of a first pharmaceutical or cosmetic, a coating agent layer that is to be absorbed into the integument, the coating agent layer encapsulating the micronized particle, a layer of either the first pharmaceutical or cosmetic, or a second pharmaceutical or cosmetic different from the first pharmaceutical or cosmetic, covering the coating agent layer, and an outer coating layer that is to be absorbed into the integument, the outer coating layer encapsulating the layer of either the first or second pharmaceutical or cosmetic.
Hammond teaches multi-layer granules for systemic administration (layer-by-layer (LbL) coated particles, as shown in Fig. 1, that can comprise various numbers of layers, c 13 ln 57 to c 14 ln 8) comprising: a micronized particle of a first pharmaceutical (col. 21, lines 38-44 describes the nanoparticle core being made hollow to compartmentalize biologics or a reservoir of drugs; col. 15, line 65-col. 16, line 5 describes various drugs and compositions that could be incorporated in the LbL films) or cosmetic (col. 16, lines 3-5 describes nutraceutical agents such as vitamins and minerals; lines 52-53 describes anti-microbials; U.S. Patent Application Publication 2002/0160965 to Lanzendorfer et al. para. 178 describes additives customary in cosmetics include vitamins and anti-microbials), a coating agent layer (Fig. 1, LbL nanofilms; col. 13, lines 45-46 describes the first layer as coating the core) that is to be absorbed into the integument (col. 15, lines 20-26 describes the layers being formed of degradable polyelectrolyte that degrades when exposed to a liquid medium such as intracellular fluid, interstitial fluid that would be present in the integument, thus the layer as it degrades is absorbed into the integument), the coating agent layer encapsulating the micronized particle (col. 13, line 45-46 describes the first layer as coating, i.e. encapsulating, the core; see also Fig. 1), a layer (Fig. 1, LbL nanofilms) of either the first pharmaceutical or cosmetic, or a second pharmaceutical or cosmetic different from the first pharmaceutical or cosmetic (col. 15, lines 26-28 describes the LbL layer degradation gradually and controllably releases releasable agents; col. 15, line 65-col. 16, line 5 describes various drugs and compositions that could be incorporated in the LbL films; and col. 16, lines 3-5 describes release agents such as vitamins and minerals; lines 52-53 describes anti-microbials, both of which are used in cosmetics), covering the coating agent layer (Fig. 1; col. 13, lines 41-56), and an outer coating layer (col. 13, lines 46-47 describes an outer layer forming the particle surface) that is to be absorbed into the integument (col. 15, lines 20-26 describes the layers being formed of degradable polyelectrolyte that degrades when exposed to a liquid medium such as intracellular fluid, interstitial fluid that would be present in the integument, thus the layer as it degrades is absorbed into the integument), the outer coating layer encapsulating the layer of either the first or second pharmaceutical or cosmetic (col. 13, lines 46-47 describes an outer layer forming the particle surface thus encapsulating the layer of either the first or second pharmaceutical or cosmetic layer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the LbL coated particles of Hammond within the biodegradable carriers of Chen 695’ for the purpose of delivering a rich diversity of therapeutic or other agents, col. 1, lines 29-35, and further to manipulate the in-vivo stability, biodistribution, targeting and/or controlled release of one or more agents, as taught by Hammond col. 8, lines 55-58.
Regarding claims 2 and 3, Chen 695’ in view of Hammond teaches the integumental dissolving needle device according to Claim 1, further comprising: additional granules housed by the plurality of dissolving needles (Chen 695’, Figs. 1, 3 and 10 show multiple additional granules incorporated into the microneedles), the additional granules comprising: a/another (a/another are interpreted as synonyms) micronized particle of the first pharmaceutical or cosmetic (as taught by Hammond, see claim 1 above), and an/another (a/another interpreted as synonyms) outer coating layer that is to be absorbed into the integument, the outer coating layer encapsulating the micronized particle (as taught by Hammond, see claim 1 above).
Regarding claims 4-5 and 7-8, Chen 695’ in view of Hammond teaches the integumental dissolving needle device according to Claims 1 and 2, wherein Chen 695’ further teaches the plurality of dissolving needles themselves are composed of one of: one or more pharmaceuticals (Chen 695’, the biodegradable carrier 12 encapsulates drugs 13).
Regarding claims 16-18, Chen 695’ in view of Hammond teaches the integumental dissolving needle according to Claims 1, 2 and 4, but does not explicitly teach the multi-layer granules further include a structure in which (1) the layer of either the first or second pharmaceutical or cosmetic, and (2) the outer coating layer that is absorbed into the integument are all repeated.
Hammond teaches the LbL coated particles can comprise various numbers of layers, c 13 ln 57 to c 14 ln 8, up to 100. Additionally, Hammond teaches controlled release of one or more agents, c 8 ln 54-59, and that releasing of agents associated with LbL films can be fine-tuned, so that dose and kinetics of releasing agents may vary depending on film design and construction, c 18 ln 50-54.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to apply a known technique to a known product ready for improvement to yield predictable results, MPEP 2143(I)(D). Hammond contained a “base” product, LbL particles, upon which the claimed invention can be seen as an “improvement”, which is repeating layers. Hammond contained a known technique that is applicable to the base device, the technique of adding layers and the use of layers for controlled release of one (or more) agents, c 8 ln 54-59. One of ordinary skill in the art would have recognized that applying the known technique would have yielded predictable results of controlled release and resulted in an improved system for delivering agents.
Regarding claims 19-20, Chen 695’ in view of Hammond teaches the needle device according to Claims 1, wherein: the patch or poultice (patch and poultice are interpreted as being used interchangeably in claim 20 because the written description only describes the poultice comprised of a tape) is comprised of a tape or surfaces of the poultice are comprised of tapes (Chen 695’, hydrogel glue patch, P0046).
Regarding claim 21-24, Chen 695’ in view of Hammond teaches the integumental dissolving needle device according to Claims 1, 2, 4 and 17.
Chen 695’ in view of Hammond do not teach wherein the coating agent is phosphate ester or phospholipids, Hyaluronic acid, trehalose, sucrose, gelatin, collagen, keratin or dextran.
However, Applicant has not indicated the claimed coating as being critical. Applicant’s P0022 describes various compositions that may be used, the critical factor being biocompatibility. The last sentence of Applicant’s P0022 recites that any biocompatible substance capable of encapsulating the pharmaceutical or cosmetic ingredients and being absorbed in the integument may be used, which includes the coatings taught by Hammond which are biocompatible. Utilizing the claimed coating will not adversely affect the coating agent of Hammond since Hammond teaches using other coatings listed in Applicant’s P0022 including biodegradable polymers, Hammond c 15 ln 43. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the coating agents of Hammond to include phosphate ester or phospholipids as claimed because it appears to an arbitrary choice which fails to patentably distinguish over Hammond.
Alternatively, claims 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Chen 695’ in view of Hammond and further in view of Ozel et al. (Ozel) US 2013/0096532 A1.
Regarding claim 21-24, Chen 695’ in view of Hammond teaches the integumental dissolving needle device according to Claims 1, 2, 4 and 17.
Chen 695’ in view of Hammond does not teach wherein the coating agent is phosphate ester or phospholipids, Hyaluronic acid, trehalose, sucrose, gelatin, collagen, keratin or dextran.
However, Ozel teaches a microneedle array that utilizes phospholipid encapsulated microbubbles, P0077.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the coating agent of Hammond with a phospholipid as taught by Ozel for the purpose of delivering bioactive agents, Ozel P0077.
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Chen 695’ in view of Hammond in view of Jung.
Regarding claims 6 and 9, Chen 695’ in view of Hammond teaches the integumental dissolving needle device according to Claims 1 and 2.
Chen 695’ does not teach the plurality of dissolving needles themselves are composed of one or more cosmetics.
However, Jung teaches a microstructure wherein the plurality of dissolving needles themselves are composed of one or more cosmetics (cosmetic ingredients, P0049).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the drugs of Chen 695’ to include cosmetics for the purpose of treating wrinkles, inhibiting skin aging or to whiten skin, Jung P0049.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chen 695’ in view of Hammond in view of Jung and further in view of Clay.
Regarding claims 13-15, Chen 695’ in view of Hammond teaches the integumental dissolving needle device according to Claims 1, 2 and 4.
Chen 695’ in view of Hammond does not teach wherein: the integumental dissolving needle device is sectionable.
However, Jung teaches a microstructures wherein the integumental dissolving needle device is sectionable (Figs. 6a, 7a, 8a, 9a, 10a; para. 59 shows the substrate or needles can be separated, i.e. sectionable, from the substrate or into smaller sizes and lengths such as by physically cutting the needles with a knife or using a laser cutter).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the dissolving needle device of Chen 695’ in view of Hammond to be sectionable as taught by Jung for the purpose of delivering an appropriate dosage.
Chen 695’ in view of Hammond in view of Jung does not teach a product name or product names and dosage or dosages written on a surface or surfaces of the integumental dissolving needle device.
Clay teaches a product name or product names and dosage or dosages written on a surface or surfaces of the [device] (Figs. 8d, 8e; para. 106 describes the drug name and dosage appearing on the surface of a ring attached to the device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included Clay’s labeling with a product name or product names and dosage or dosages written on a surface or surfaces of the integumental dissolving needle device of Chen 695’ in view of Hammond in view of Jung “to facilitate selection of a drug delivery device containing the correct drug” (para. 67) as taught by Clay.
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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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783