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 19 August 2026. As directed by the amendment: claims 1, 11, 12, 18, 20, and 29 have been amended; claims 13 and 14 have been canceled; and no claims have been added. Thus, claims 1, 2, 6-12, 17-21, and 27-29 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 7, filed 19 August 2026, with respect to the rejection(s) of claim(s) 1, 2, 6-8, 17, 18, 28, and 29 under 35 USC §102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hong et al (“Characterization of ovalbumin-containing polyurethane microcapsules with different structures”, attached herein).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 6-8, 13, 14, 17, 18, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (US 2014/0005606) in view of Hong et al (“Characterization of ovalbumin-containing polyurethane microcapsules with different structures”, attached herein).
Regarding claim 1, Chen discloses:
A dissolvable microneedle patch (Abstract – biodegradable micro-needle patch) for delivery of a therapeutically active ingredient to the skin (Abstract – transdermal drug delivery) comprising: a plurality of microneedles (11; Fig. 1); and a removable substrate (102); wherein the plurality of microneedles (11) are attached to the removable substrate (102); wherein the plurality of microneedles (11) comprise a tapered tip that extends away from the removable substrate (102); wherein the plurality of microneedles (11) comprise a biodegradable polymer (¶0041) and a therapeutically active ingredient (12; ¶0044) dispersed in the biodegradable polymer (11).
Chen discloses all of the elements of the claim but is silent regarding “wherein the therapeutically active ingredient is an antigen composition comprising glycerol in an amount of about 0.1% to about 50%.” However, Hong teaches encasing active ingredients like ovalbumin (like the active ingredient of Chen, see ¶0062) in microcapsules comprising glycerol in order to provide the highest thermal stability (Abstract). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided glycerol in the microcapsules of Chen as taught by Hong in order to improve the thermal stability of the active ingredient, as recognized by Hong.
Chen and Hong are silent regarding the amount of glycerol in the antigen composition, although Hong teaches the method of incorporating the glycerol within the microcapsule (Hong, page 976). However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the percentage amount of glycerol in the device of Chen modified by Hong to have an amount of about 0.1% to about 50% since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Chen modified by Hong would not operate differently with the claimed amount of glycerol since the glycerol improves the thermal stability and would depend on the properties desired by a user. Further, it appears that applicant places no criticality on the range claimed, indicating several different ranges for the glycerol amount (instant ¶0078).
Regarding claim 2, Chen in view of Hong discloses:
The dissolvable microneedle patch of claim 1, wherein the plurality of microneedles (11) contain an excipient to stabilize the antigen composition, wherein the excipient is selected from at least one of lactose, sucrose, glucose, mannitol, sorbitol, trehalose, fructose, galactose, dextrose, xylitol, maltitol, raffinose, dextran, maltodextrin, cyclodextrin, collagen, glycine, histidine, calcium carbonate, magnesium stearate, serum albumin (human and/or animal sources), gelatin, chitosan (¶0050), deoxyribonucleic acid (DNA), hyaluronic acid, polyvinylpyrrolidone, polyvinyl alcohol, polylactic acid (PLA), polyglycolic acid (PGA), polyactive co-glycolic acid (PLGA), polyethylene glycol (PEG, PEG300, PEG400, PEG600, PEG3350, PEG4000), cellulose, methylcellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, acacia, Lecithin, Polysorbate 20, Polysorbate 80, Pluronic F-68, Sorbitantrioleate (span 85), EDTA, hydroxypropyl cellulose, sodium chloride, sodium phosphate, ammonium acetate, potassium phosphate, sodium citrate, sodium hydroxide, sodium carbonate, Tris base-65, Tris acetate, Tris HCl-65, citrate buffer, talc, silica, fats, methyl paraben, propyl paraben, selenium, vitamins (A, E, C, retinyl palmitate, and selenium), amino acids (methionine, cysteine, arginine), citric acid, sodium citrate, benzyl alcohol, chlorbutanol, cresol, phenol, thimerosal, acetone, sodium bisulfate, ascorbyl palmitate, ascorbate, castor oil, cottonseed oil, alum, aluminum hydroxide, aluminum phosphate, calcium phosphate hydroxide, paraffin oil, squalene, Quil A, IL-1, IL-2, IL-12, Freund's complete adjuvant, Freund's incomplete adjuvant, killed Bordetella pertussis, Mycobacterium bovis, and toxoids.
Regarding claim 6, Chen in view of Hong discloses:
The dissolvable microneedle patch of claim 1, wherein the plurality of microneedles can range from about 10 microns to about 1000 microns (¶0041 – 400-800 micron).
Regarding claim 7, Chen in view of Hong discloses:
The dissolvable microneedle patch of claim 1, wherein the plurality of microneedles (11) each comprise about the same amount of the therapeutically active ingredient (¶0052 – each microneedle is formed in the same way and therefore has about the same amount of drug).
Regarding claim 8, Chen in view of Hong discloses:
The dissolvable microneedle patch of claim 1, wherein the plurality of microneedles (11) each comprise unequal amount of the therapeutically active ingredient (¶0052 – the gel containing the drug is placed in the mold and centrifuged, so the exact amount of drug in each microneedle may differ slightly).
Regarding claim 17, Chen in view of Hong discloses:
The dissolvable microneedle patch of claim 1, wherein the plurality of microneedles are configured to have a sustained release of therapeutically active ingredient into the skin (¶0044).
Regarding claim 18, Chen in view of Hong discloses:
The dissolvable microneedle patch of claim 17, wherein the plurality of microneedles are configured to release the therapeutically active ingredient from about 1 day to about 30 days after application of the dissolvable microneedle patch into the skin (¶0068 – seven days).
Regarding claim 28, Chen discloses:
The dissolvable microneedle patch of claim 1, wherein the therapeutically active ingredient stimulates a local immune response (¶0063).
Regarding claim 29, Chen discloses:
A method of treating a skin condition (Abstract) comprising: i) applying a dissolvable microneedle patch (1; Fig. 1) for delivery of a therapeutically active ingredient (12) to the skin comprising: a plurality of microneedles (11) comprising microneedles (11); and a removable substrate (102); wherein the plurality of microneedles (11) are attached to the removable substrate (102); wherein the plurality of microneedles (11) comprise a tapered tip that extends away from the removal substrate (102); wherein the plurality of microneedles (11) comprise a biodegradable polymer (¶0039) and a therapeutically active ingredient (12) dispersed in the biodegradable polymer (11); and ii) exerting sufficient force on the dissolvable microneedle patch (1) to permit the microneedles (11) to penetrate to a location selected from the group consisting of the epidermis, the dermis, and the papillary dermis (¶0041 - epidermis); and iii) allowing the plurality of microneedles (11) to remain in the skin until the biodegradable polymer degrades (¶0010); and iv) removing the removable substrate from the dissolvable microneedle patch (¶0055 – the supporting substrate 102 has the adhesive and the substrate 102 can be removed easily by the user).
Chen discloses all of the elements of the claim but is silent regarding “wherein the therapeutically active ingredient is an antigen composition comprising glycerol in an amount of about 0.1% to about 50%.” However, Hong teaches encasing active ingredients like ovalbumin (like the active ingredient of Chen, see ¶0062) in microcapsules comprising glycerol in order to provide the highest thermal stability (Abstract). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided glycerol in the microcapsules of Chen as taught by Hong in order to improve the thermal stability of the active ingredient, as recognized by Hong.
Chen and Hong are silent regarding the amount of glycerol in the antigen composition, although Hong teaches the method of incorporating the glycerol within the microcapsule (Hong, page 976). However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the percentage amount of glycerol in the device of Chen modified by Hong to have an amount of about 0.1% to about 50% since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Chen modified by Hong would not operate differently with the claimed amount of glycerol since the glycerol improves the thermal stability and would depend on the properties desired by a user. Further, it appears that applicant places no criticality on the range claimed, indicating several different ranges for the glycerol amount (instant ¶0078).
Claims 9-12 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Hong further in view of Henderson (US 2017/0196966).
Regarding claim 9, Chen in view of Hong discloses the dissolvable microneedle patch of claim 1 but is silent regarding “the antigen composition comprises an antigen selected from the group consisting of Candida antigen, Trichophyton antigen, tuberculin, Corynebacterium parvum, Cutibacterium acnes, and Mycobacterium indicus pranii (formerly Mycobacterium w), imiquimod, human papillomavirus vaccine, measles-mumps-rubella vaccine, mumps vaccine, Bacillus Calmette-Guérin vaccine, and the Mycobacterium w vaccine.” However, Henderson teaches a drug-carrying microneedle (Abstract), thus being in the same field of endeavor, comprising Candida antigen (¶0053, 0076). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the antigen of Chen to incorporate Candida antigen as taught by Henderson in order to provide sufficient medication to treat a desired condition.
Regarding claim 10, Chen in view of Hong discloses the dissolvable microneedle patch of claim 1 but is silent regarding “the antigen composition comprises Candida antigen.” However, Henderson teaches a drug-carrying microneedle (Abstract), thus being in the same field of endeavor, comprising Candida antigen (¶0053, 0076). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the antigen of Chen to incorporate Candida antigen as taught by Henderson in order to provide sufficient medication to treat a desired condition.
Regarding claim 11, Chen in view of Hong and Henderson discloses the dissolvable microneedle patch of claim 10, wherein the antigen composition comprising Candida antigen taught by Henderson in the rejection of claim 10 is substantially free of glycerol (¶0131 – glycerol is only used with oral therapies, as the glycerol protects the drug from gastric mucosa).
Regarding claim 12, Chen in view of Hong and Henderson discloses the dissolvable microneedle patch of claim 11, wherein the antigen composition comprising Candida antigen taught by Henderson in the rejection of claim 10 is lyophilized (¶0102).
Regarding claim 27, Chen in view of Hong discloses the dissolvable microneedle patch of claim 1 but is silent regarding “the microneedle patch administers to a subject in need thereof a therapeutically effective amount of Candida antigen.” However, Henderson teaches a drug-carrying microneedle (Abstract), thus being in the same field of endeavor, comprising Candida antigen (¶0053, 0076). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the antigen of Chen to incorporate Candida antigen as taught by Henderson in order to provide sufficient medication to treat a desired condition.
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Hong further in view of Lee et al (US 2009/0182306).
Regarding claim 19, Chen in view of Hong discloses the dissolvable microneedle patch of claim 1 but is silent regarding “an immediate release of therapeutically active ingredient into the skin.” However, Lee teaches a transdermal microneedle device (Abstract), thus being in the same field of endeavor, that uses multiple modes of delivery, including immediate release (by dissolving rapidly) and/or sustained release (by having a longer and slower diffusion rate of the drug) (¶0036). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the drug release rate of Chen to incorporate an immediate release rate as taught by Lee in order to allow different release rates for optimizing drug delivery, as recognized by Lee.
Regarding claim 20, Chen in view of Hong and Lee discloses the dissolvable microneedle patch of claim 19, wherein the plurality of microneedles as modified by Lee in the rejection of claim 19 are configured to release the therapeutically active ingredient from about 0 hours to about 24 hours after application of the dissolvable microneedle patch into the skin (¶0036 – immediate release, i.e. 0 hours).
Regarding claim 21, Chen in view of Hong discloses the dissolvable microneedle patch of claim 1 but is silent regarding “the plurality of microneedles are configured to have both sustained release and an immediate release of therapeutically active ingredient into the skin.” However, Lee teaches a transdermal microneedle device (Abstract), thus being in the same field of endeavor, that uses multiple modes of delivery, including immediate release (by dissolving rapidly) and/or sustained release (by having a longer and slower diffusion rate of the drug) (¶0036). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the drug release rate of Chen to incorporate an immediate release rate as taught by Lee in order to allow different release rates for optimizing drug delivery, as recognized by Lee.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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