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 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 15, 43-49 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 15 recites the limitation “a polymer” in line 2. It is unclear if it is referring to the limitation as in claim 1, line 4 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the line 4 of claim 1.
Claim 43 recites the limitation “a dissolvable microneedle patch perilesionally, the dissolvable microneedle patch comprising a first plurality of microneedles and a second plurality of microneedles, a therapeutically active ingredient , and a biodegradable polymer ; wherein the first plurality of microneedles deliver therapeutically active ingredient perilesionally; and wherein the second plurality of microneedles deliver therapeutically active ingredient directly to the skin lesion" in lines 2-7. It is unclear if it means that a portion of the microneedles patch are applied to the skin lesion and other remaining portion are not located on the skin lesion see Fig. 18 or it means two patches one is located on skin lesion and the other located outside the skin lesion see Fig. 19. For the purpose of examination, the examiner will interpret the limitation as in Fig.18 as a portion of the microneedle are located directly on skin lesion and other portion are not on the lesion.
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.
Claim(s) 1-3, 5-15, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henderson (US 20170196966 A1) in view of Martyn (US 2020002905A1).
Re claim 1, Henderson discloses a method of treating a skin condition (abstract, Fig.1-21, ¶0042) comprising: i) applying a dissolvable microneedle patch (¶0005), the dissolvable microneedle patch comprising a plurality of microneedles (¶0049, ¶0043); a therapeutically active ingredient (antigen such as Candida albicans, ¶0076) and a biodegradable polymer (¶0048); ii) exerting sufficient force on the dissolvable microneedle patch to permit the plurality of microneedles to penetrate to a location selected from the group consisting of the epidermis, the dermis, and the papillary dermis (¶0045); and iii) allowing the plurality of microneedles to remain in the skin until the biodegradable polymer degrades (¶0049), but fails to disclose that applying the dissolvable microneedle patch is perilesionally.
However, Martyn discloses a method of delivering a vaccine for immune stimulatory and wherein it can be administered perilesionally by microneedle ( see pg 1,lines 12-15, pg 39, lines 26-23, pg 51,lines 20-24).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Henderson so that the step of applying the dissolvable microneedle patch is perilesionally as taught by Martyn for the purpose of administrating the agent in an art recognized administration path (Martyn, pg 39, lines 26-23).
Re claim 2, Henderson discloses wherein the skin condition is selected from the group comprising a wart, condyloma acuminatum, Bowenoid papulosis, molluscum contagiosum, actinic keratosis, squamous cell carcinoma, basal cell carcinoma, verrucous carcinoma, epidermodysplasia verruciformis, Gorlin's syndrome, and alopecia areata, and vitiligo (wart ,¶0114).
Re claim 3, the modified Henderson discloses wherein the dissolvable microneedle patch is applied perilesionally (see Martyn pg 1,lines 12-15, pg 39, lines 26-23, pg 51, lines 20-24) but it is silent as to the specifics applied distance of the from about 0.5 mm to about 100 mm from a skin lesion. The instant disclosure describes the parameter of the applied distance as being merely preferable (see ¶0074 of the current application), and does not describe the applied distance as contributing any unexpected results to the system. As such, parameters such as applied distance are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the applied distance of the microneedles would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Re claim 5, Henderson discloses wherein the therapeutically active ingredient stimulates a local immune response (¶0041).
Re claim 6, Henderson discloses wherein the therapeutically active ingredient is selected from the group consisting of a vaccine (the human papillomavirus, ¶0074), an immune stimulating molecule, an immune stimulating organism, and an immune stimulating protein (Candida albicans is an immune stimulating antigen protein ¶0076).
Re claim 7, Henderson discloses wherein the vaccine is selected from the group consisting of the measles-mumps-rubella vaccine, mumps vaccine, the human papillomavirus vaccine, Bacillus Calmette-Guerin vaccine, and the Mycobacterium w vaccine (the human papillomavirus, ¶0074).
Re claim 8, Henderson discloses wherein the immune stimulating protein is Candida antigen (Candida albicans is an immune stimulating antigen protein ¶0076).
Re claim 9, Henderson discloses wherein the Candida antigen is substantially free of glycerin (Candida albicans is an immune stimulating antigen protein ¶0076).
Re claim 10, Henderson discloses wherein the Candida antigen is lyophilized (¶0102).
Re claim 11, Henderson fails to disclose wherein the immune stimulating organism is selected from the group consisting of Propionbacterium Cutibacterium acnes, Corynebacterium parvum, Priopionobacterium, and Mycobacterium indicus pranii.
However, Martyn discloses a method of delivering a vaccine for immune stimulatory and wherein it can be administered perilesionally by microneedle ( see pg 1,lines 12-15, pg 39, lines 26-23, pg 51,lines 20-24) and the agent can be the Mycobacterium indicus pranii (pg 8, lines 6-26, pg 23, lines 16-31).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Henderson so that the immune stimulating organism is selected from the group consisting of Propionbacterium Cutibacterium acnes, Corynebacterium parvum, Priopionobacterium, and Mycobacterium indicus pranii as taught by Martyn for the purpose of administrating the agent for stimulating target cell for treatment ( (Martyn, pg 8, lines 6-26).
Re claim 12, Henderson discloses wherein the immune stimulating protein selected from the group consisting of Candida antigen, trichophyton antigen, tuberculin, purified protein derivative, human papillomavirus surface proteins, interferon alpha, interferon beta, and interferon gamma (the human papillomavirus, ¶0074 or Candida albicans is an immune stimulating antigen protein ¶0076).
Re claim 13, Henderson discloses wherein the plurality of microneedles are attached to a removable adhesive substrate (¶0177, adhesive bandage).
Re claim 15, Henderson discloses wherein the removable adhesive substrate comprises a therapeutically active ingredient dispersed in a polymer (¶0130).
Re claim 26, Henderson discloses wherein the plurality of microneedles are configured to have a sustained release of therapeutically active ingredient into the skin configured to have an immediate release of therapeutically active ingredient into the skin, and combination thereof (¶0113).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henderson (in view of Martyn and further in view of Kato et al. (US 20170196966 A1) (“Kato”).
Re claim 4, Henderson fails to discloses that the method is comprising applying a second microneedle patch directly on a skin lesion.
However, Kato discloses a method of treating a skin condition (abstract, Fig.1-12, ¶0037) comprising: i) applying a dissolvable microneedle patch (21s and 31s, ¶0026) perilesionally (see 112 rejection above), the dissolvable microneedle patch comprising a first plurality of microneedles (21s) and a second plurality of microneedles (31s), a therapeutically active ingredient (¶0081), and a biodegradable polymer (¶0047); and wherein the second plurality of microneedles deliver therapeutically active ingredient directly to the skin lesion (¶0065).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Henderson so that that the method is comprising applying a second microneedle patch directly on a skin lesion. as taught by Kato for the purpose of administrating the different agents to treat the target area ( Kato, ¶0050).
Claim(s) 43, 45-46, 48-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kato et al. (US 20170196966 A1) (“Kato”) in view of Martyn (US 2020002905A1).
Re claim 43, Kato discloses a method of treating a skin condition (abstract, Fig.1-12, ¶0037) comprising: i) applying a dissolvable microneedle patch (21s and 31s, ¶0026) perilesionally (see 112 rejection above), the dissolvable microneedle patch comprising a first plurality of microneedles (21s) and a second plurality of microneedles (31s), a therapeutically active ingredient (¶0081), and a biodegradable polymer (¶0047); and wherein the second plurality of microneedles deliver therapeutically active ingredient directly to the skin lesion (¶0065); ii) exerting sufficient force on the dissolvable microneedle patch to permit the first plurality of microneedles and the second plurality of microneedles to penetrate to a location selected from the group consisting of the epidermis, the dermis, and the papillary dermis (¶0037); and iii) allowing the first plurality of microneedles and the second plurality of microneedles to remain in the skin until the biodegradable polymer degrades (¶0066), but it fails to disclose that the first plurality of microneedles deliver therapeutically active ingredient perilesionally.
However, Martyn discloses a method of delivering a vaccine for immune stimulatory and wherein it can be administered perilesionally by microneedle ( see pg 1,lines 12-15, pg 39, lines 26-23, pg 51,lines 20-24).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kato so that the step of the first plurality of microneedles deliver therapeutically active ingredient perilesionally as taught by Martyn for the purpose of administrating the agent in an art recognized administration path ( (Martyn, pg 39, lines 26-23).
Re claim 45, Kato discloses wherein the therapeutically active ingredient is selected from the group consisting of a vaccine, an immune stimulating molecule, an immune stimulating organism, and an immune stimulating protein (vaccine ¶0051).
Re claim 46, Kato fails to disclose wherein the vaccine is selected from the group consisting of the measles-mumps-rubella vaccine, mumps vaccine, the human papillomavirus vaccine, Bacillus Calmette-Guerin vaccine, and the Mycobacterium vaccine.
However, Martyn discloses a method of delivering a vaccine for immune stimulatory and wherein it can be administered perilesionally by microneedle ( see pg 1,lines 12-15, pg 39, lines 26-23, pg 51,lines 20-24) and the agent can be the Mycobacterium vaccine (pg 8, lines 6-26, pg 23, lines 16-31).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kato so that the vaccine is selected from the group consisting of the measles-mumps-rubella vaccine, mumps vaccine, the human papillomavirus vaccine, Bacillus Calmette-Guerin vaccine, and the Mycobacterium vaccine as taught by Martyn for the purpose of administrating the agent for stimulating target cell for treatment ( (Martyn, pg 8, lines 6-26).
Re claim 48, Kato fails to disclose wherein the immune stimulating organism is selected from the group consisting of Propionbacterium Cutibacterium acnes, Corynebacterium parvum, Priopionobacterium, and Mycobacterium indicus pranii.
However, Martyn discloses a method of delivering a vaccine for immune stimulatory and wherein it can be administered perilesionally by microneedle ( see pg 1,lines 12-15, pg 39, lines 26-23, pg 51,lines 20-24) and the agent can be the Mycobacterium indicus pranii (pg 8, lines 6-26, pg 23, lines 16-31).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kato so that the immune stimulating organism is selected from the group consisting of Propionbacterium Cutibacterium acnes, Corynebacterium parvum, Priopionobacterium, and Mycobacterium indicus pranii as taught by Martyn for the purpose of administrating the agent for stimulating target cell for treatment ( (Martyn, pg 8, lines 6-26).
Re claim 49, Kato fails to disclose wherein the immune stimulating protein selected from the group consisting of Candida antigen, trichophyton antigen, tuberculin, purified protein derivative, human papillomavirus surface proteins, interferon alpha, interferon beta, and interferon gamma.
However, Martyn discloses a method of delivering a vaccine for immune stimulatory and wherein it can be administered perilesionally by microneedle ( see pg 1,lines 12-15, pg 39, lines 26-23, pg 51,lines 20-24) and the agent can be interferon gamma (IFN- gamma pg 58, lines 6-13).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kato so that the immune stimulating protein selected from the group consisting of Candida antigen, trichophyton antigen, tuberculin, purified protein derivative, human papillomavirus surface proteins, interferon alpha, interferon beta, and interferon gamma as taught by Martyn for the purpose of administrating the agent for stimulating target cell for treatment ( (Martyn, pg 8, lines 6-26).
Claim(s) 44, 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kato in view of Martyn and further in view of Henderson.
Re claim 44, Kato fails to disclose wherein the skin condition is selected from the group comprising a wart, condyloma acuminatum, Bowenoid papulosis, molluscum contagiosum, actinic keratosis, squamous cell carcinoma, basal cell carcinoma, verrucous carcinoma, epidermodysplasia verruciformis, Gorlin's syndrome, and alopecia areata, and vitiligo.
However, Henderson discloses wherein the skin condition is selected from the group comprising a wart, condyloma acuminatum, Bowenoid papulosis, molluscum contagiosum, actinic keratosis, squamous cell carcinoma, basal cell carcinoma, verrucous carcinoma, epidermodysplasia verruciformis, Gorlin's syndrome, and alopecia areata, and vitiligo (wart ,¶0114).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kato so that the skin condition is selected from the group comprising a wart, condyloma acuminatum, Bowenoid papulosis, molluscum contagiosum, actinic keratosis, squamous cell carcinoma, basal cell carcinoma, verrucous carcinoma, epidermodysplasia verruciformis, Gorlin's syndrome, and alopecia areata, and vitiligo as taught by Henderson for the purpose of administrating the agent for stimulating target cell for treatment with several infected condition ( (Henderson, ¶0114).
Re claim 47, Kato fails to disclose wherein the immune stimulating protein is Candida antigen.
Henderson discloses the method of delivering the immune stimulating protein such as Candida antigen (Candida albicans is an immune stimulating antigen protein ¶0076).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kato so that the immune stimulating protein is Candida antigen as taught by Martyn for the purpose of administrating the agent for stimulating target cell for treatment with several infected condition ( (Henderson, ¶0076).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783