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. Claim Objections Claims 11, 12, 18, and 20 are objected to because of the following informalities: In claim 11, line 1: “ The immune stimulating protein of claim 10 ” should be “The dissolvable microneedle patch of claim 10, wherein the antigen composition… ” In claim 12, line 1: “ The Candida antigen of claim 11 ” should be “ The dissolvable microneedle patch of claim 1 1” In claim 18, line 1: “ The sustained release microneedles of claim 17, are configured ” should be “The dissolvable microneedle patch of claim 17, wherein the microneedles configured for sustained release are… ” In claim 20, line 1: “ The immediate release microneedles of claim 19, are configured ” should be “The dissolvable microneedle patch of claim 19, wherein the microneedles are configured …” Appropriate correction is required. 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 appl icant regards as his invention. Claims 11 , 12, and 29 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 11 recites the limitation "The immune stimulating protein" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be interpreted based on the objection made above. Claim 29 recites the limitation "the patch composition" in line 18. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be interpreted as “a patch composition.” Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claims 1, 2, 6-8, 13, 14, 17, 18, 28, and 29 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Chen et al (US 2014/0005606) . 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) ; and wherein the therapeutically active ingredient (12) is an antigen composition comprising less than 50% glycerol (¶0062 – ovalbumin, an antigen ) . Regarding claim 2 , Chen 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 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 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 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 13 , Chen discloses: The dissolvable microneedle patch of claim 1, wherein the antigen composition is substantially free of glycerol (¶0062 – the antigen composition is ovalbumin, with no disclosure of any glycerol ) . Regarding claim 14 , Chen discloses: The dissolvable microneedle patch of claim 1, wherein the antigen composition comprises less than about 10% glycerol (¶0062 – the antigen composition is ovalbumin, with no disclosure of any glycerol ) . Regarding claim 17 , Chen 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 discloses: The sustained release microneedles of claim 17, 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 wherein the therapeutically active ingredient (12) is an antigen composition comprising less than 50% glycerol (¶0062 – ovalbumin, an antigen ) ; 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 adhesive substrate from the patch composition (¶0055 – the supporting substrate 102 has the adhesive and the substrate 102 can be removed easily by the user ) . 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. 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 9-12 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Henderson (US 2017/0196966) . Regarding claim 9 , Chen 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 Henderson 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 Henderson discloses the immune stimulating protein 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 Henderson discloses the Candida antigen 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 Henderson 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 Lee et al (US 2009/0182306) . Regarding claim 19 , Chen 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 Lee discloses the dissolvable microneedle patch of claim 19, wherein the immediate release microneedles taught 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 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 Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT TASNIM M AHMED whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9536 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9am-5pm Pacific time . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Bhisma Mehta can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)272-3383 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /TASNIM MEHJABIN AHMED/ Primary Examiner, Art Unit 3783