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 .
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is not within the range of 50 to 150 words in length. Currently the Abstract is 35 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 12, 18, 20, 27, 29, 31, 32, and 33 are objected to because of the following informalities:
Claim 12 recites:
The glycerin free Candida antigen of claim 11, wherein the Candida antigen is lyophilized.
Claim 12 is objected to because the preamble (e.g. “The glycerin free Candida antigen of claim 11”) is different than the preamble for the other dependent claims. The Examiner suggests amending the preamble to correct this inconsistency.
Claim 18 is objected to because the preamble (e.g., “The sustained release microneedles of claim 17”) is different than the preamble for the other dependent claims. The Examiner suggests amending the preamble to correct this inconsistency.
Claim 20 is objected to because the preamble (e.g., “The immediate release microneedles of claim 19”) is different than the preamble for the other dependent claims. The Examiner suggests amending the preamble to correct this inconsistency.
Claim 27 recites “the microneedle patch.” The Examiner suggests amending this to recite “the dissolvable microneedle patch” to provide proper antecedent basis for the claim limitation.
Claim 29 recites “from the removal substrate.” The Examiner suggests amending this to recite “from the removable substrate” to provide proper antecedent basis for the claim limitation.
Claim 29 recites “the active ingredient is selected…wherein the active ingredient is substantially free.” The Examiner suggests amending these passages to recite “the therapeutically active ingredient is selected…wherein the therapeutically active ingredient is substantially” to provide proper antecedent basis for the claim limitations.
Claim 29 recites “to permit the microneedles.” The Examiner suggests amending this to recite “to permit the plurality of microneedles” to provide proper antecedent basis for this claim limitation.
Claim 29 recites “.;” within step iii). The Examiner suggests amending this step to remove the period before the semi-colon.
Claim 31 recites “the microneedles detach.” The Examiner suggests amending this to recite “the plurality of microneedles detach” to provide proper antecedent basis for the claim limitation.
Claim 32 recites “releases therapeutically active ingredient.” The Examiner suggests amending this to recite “releases the therapeutically active ingredient” to provide proper antecedent basis for this claim limitation.
Claim 33 recites “releases therapeutically active ingredient.” The Examiner suggests amending this to recite “releases the therapeutically active ingredient” to provide proper antecedent basis for this claim limitation.
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 applicant regards as his invention.
Claims 12 and 29 – 33 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 is cancelled in the Claims dated 26 July 2024.
Claim 12 recites:
The glycerin free Candida antigen of claim 11, wherein the Candida antigen is lyophilized.
Claim 12 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it is unclear what the dependency of Claim 12 is intended to be. Since the dependency of Claim 12 is unknown the metes and bounds of Claim 12 is then unknown.
Claim 29 recites “removing adhesive substrate from the patch composition.” There is a lack of antecedent basis for the “adhesive substrate” and the “patch composition.”
Claims 30 – 33 are rejected under 35 U.S.C. § 112(b) by virtue of their dependency on Claim 29.
Claim 31 recites “the adhesive surface of the substrate upon removal of the substate.” There is a lack of antecedent basis for the limitations of “the adhesive surface” and “the substrate.” Is each recitation of the substrate referring to the removable substrate of Claim 29 or a different substrate?
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 is cancelled in the Claims dated 26 July 2024.
Claim 12 recites:
The glycerin free Candida antigen of claim 11, wherein the Candida antigen is lyophilized.
Claim 12 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends or for failing to include all the limitations of the claim upon which it depends because the dependency of Claim 12 is unknown.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 26, 29, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alary et al. (US 2018/0177990 A1) (hereinafter referred to as “Alary”) and Joshi-Hangal et al. (US 2019/0085018 A1) (hereinafter referred to as “Joshi”).
With regards to claim 1, Alary discloses (Figs. 1 and 4) a dissolvable microneedle patch (10) (see [0025]) for delivery of a therapeutically active ingredient (see [0023] and [0029] “benefit agent”) to the skin comprising:
a plurality of microneedles (30)(see [0025]) comprising microneedles (30a, 30c) of at least two different lengths (see [0032] and Figure 4); and
a removable substrate (20) (see [0025] and [0052]);
wherein the plurality of microneedles are attached to the removable substrate (see [0025] and Fig. 4);
wherein the plurality of microneedles comprise a tapered tip that extends away from the removable substrate (see [0035] “individual microneedles 30 are tapered from the first, outwardly facing major surface 22 of microneedle array 10 to a point distal therefrom. In various embodiments, the tapered tip portion may be in the form of an oblique angle at the tip, or a pyramidal or conical or triangular shape” and see Fig. 4);
wherein the plurality of microneedles comprise a biodegradable polymer (see [0050] “microneedles 30, 130, 230, or both, are formed of biodegradable or bioabsorbable materials” and [0052]) and a therapeutically active ingredient dispersed in the biodegradable polymer (see [0052] and [0056] where the benefit agent is the therapeutically active ingredient); and
wherein the therapeutically active ingredient is selected from the group consisting of a vaccine (see [0023] “As used herein, “benefit agent” means an ingredient or material that provides a benefit…These terms all refer to…vaccines”), an immune stimulating molecule, an immune stimulating organism, and an immune stimulating protein.
However, Alary is silent with regards to:
wherein the therapeutically active ingredient is substantially free of glycerin.
Nonetheless Joshi, which is within the analogous art of drug compound and purification methods thereof (see abstract and title), teaches wherein the therapeutically active ingredient is substantially free of glycerin (see [0124] “The lyophilized pharmaceutical compositions described herein can be reconstituted in solvent,” [0125] “Non-limiting examples of suitable solvents include propylene glycol, glycerin,” and [0127] “ A mixture of solvents can contain a percentage of glycerin on either a mass or a volume basis. In sonic embodiments, the percentage of glycerin can be at least 5%, at least 10%...In some embodiments, the percentage of glycerin can be 0%, 5%, 10%”) (Additionally, see [0039] of the Specification dated 9 May 2024 of the current Application where “substantially free” is defined to mean that a specified substance referred to is present in amounts not more than 10% by weight or volume of the total composition”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the therapeutic active ingredient of the dissolvable microneedle patch of Alary in view of a teaching of Joshi such that the therapeutically active ingredient is substantially free of glycerin. One of ordinary skill in the art would have been motivated to make this modification because Joshi teaches that it is common to reconstitute a lyophilized pharmaceutical composition within a solvent such as glycerin so that the pharmaceutical composition can be administered to a subject via injectable liquid compositions. See [0124], [0125], and [0127] of Joshi.
The dissolvable microneedle patch of Alary modified in view of a teaching of Joshi will hereinafter be referred to as the dissolvable microneedle patch of Alary and Joshi.
With regards to claim 26, the dissolvable microneedle patch of Alary and Joshi teaches the claimed invention of claim 1, and Alary further teaches wherein the removable substrate (20) (see [0025] and [0052]) comprises an adhesive medical tape (see [0028]).
With regards to claim 29, Alary discloses (see Figs. 1 and 4) a method of treating a skin condition (see [0001]) comprising:
i) applying a dissolvable microneedle patch (10) (see [0025]) for delivery of a therapeutically active ingredient (see [0023] and [0029] “benefit agent”) to the skin comprising:
a plurality of microneedles (30) (see [0025]) comprising microneedles (30a, 30c) of at least two different lengths (see [0032] and Fig. 4); and
a removable substrate (20) (see [0025] and [0052]);
wherein the plurality of microneedles are attached to the removable substrate (see [0025] and Fig. 4);
wherein the plurality of microneedles comprise a tapered tip that extends away from the removal substrate (see [0035] “individual microneedles 30 are tapered from the first, outwardly facing major surface 22 of microneedle array 10 to a point distal therefrom. In various embodiments, the tapered tip portion may be in the form of an oblique angle at the tip, or a pyramidal or conical or triangular shape” and see Fig. 4); and
wherein the plurality of microneedles comprise a biodegradable polymer (see [0050] “microneedles 30, 130, 230, or both, are formed of biodegradable or bioabsorbable materials” and [0052]) and a therapeutically active ingredient dispersed in the biodegradable polymer (see [0052] and [0056] where the benefit agent is the therapeutically active ingredient); and
wherein the active ingredient is selected from the group consisting of a vaccine (see [0023] “As used herein, “benefit agent” means an ingredient or material that provides a benefit…These terms all refer to…vaccines”), an immune stimulating molecule, an immune stimulating organism, and an immune stimulating protein.
ii) exerting sufficient force on the dissolvable microneedle patch to permit the microneedles to penetrate to a location selected from the group consisting of the epidermis, the dermis, and the papillary dermis (see [0030] – [0032], [0042], [0043], and Fig. 7); and
iii) allowing the plurality of microneedles to remain in the skin until the biodegradable polymer degrades (see [0052]); and
iv) removing adhesive substrate from the patch composition (see [0028] and [0052]).
However Alary is silent with regards to the following:
wherein the active ingredient is substantially free of glycerin.
Nonetheless Joshi, which is within the analogous art of drug compound and purification methods thereof (see abstract and title), teaches wherein the therapeutically active ingredient is substantially free of glycerin (see [0124] “The lyophilized pharmaceutical compositions described herein can be reconstituted in solvent,” [0125] “Non-limiting examples of suitable solvents include propylene glycol, glycerin,” and [0127] “ A mixture of solvents can contain a percentage of glycerin on either a mass or a volume basis. In sonic embodiments, the percentage of glycerin can be at least 5%, at least 10%...In some embodiments, the percentage of glycerin can be 0%, 5%, 10%”) (Additionally, see [0039] of the Specification dated 9 May 2024 where “substantially free” is defined to mean that a specified substance referred to is present in amounts not more than 10% by weight or volume of the total composition”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the active ingredient of the dissolvable microneedle patch of the method of Alary in view of a teaching of Joshi such that the therapeutically active ingredient is substantially free of glycerin. One of ordinary skill in the art would have been motivated to make this modification because Joshi teaches that it is common to reconstitute a lyophilized pharmaceutical composition within a solvent such as glycerin so that the pharmaceutical composition can be administered to a subject via injectable liquid compositions. See [0124], [0125], and [0127] of Joshi.
The method of Alary modified in view of a teaching of Joshi will hereinafter be referred to as the method of Alary and Joshi.
With regards to claim 32, the method of Alary and Joshi teaches the claimed invention of claim 29, and Alary further teaches wherein the biodegradeable polymer (see [0050] “microneedles 30, 130, 230, or both, are formed of biodegradable or bioabsorbable materials”) degrades and releases therapeutically active ingredient into the skin (see [0052] and [0056] where the benefit agent is the therapeutically active ingredient).
Claim(s) 8, 10, 12, 14, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alary and Joshi as applied to claim 1 above, and further in view of Kendall (US 2011/0245776 A1).
With regards to claim 8, the dissolvable microneedle patch of Alary and Joshi teaches the claimed invention of claim 1, however Alary is silent with regards to further teaches 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.
Nonetheless Kendall, which is within the analogous art of delivery devices (see abstract and title), teaches the vaccine is selected from the group consisting of the measles-mumps-rubella vaccine (see [0301] “measles, mumps, rubella”), mumps vaccine (see [0301] “mumps”), the human papillomavirus vaccine (see [0298] “human papillomavirus” and [0301] “papillomavirus”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the vaccine of the dissolvable microneedle patch of Alary and Joshi in view of a teaching of Kendall such that the vaccine is selected from the group consisting of the measles-mumps-rubella vaccine, mumps vaccine, the human papillomavirus vaccine. One of ordinary skill in the art would have been motivated to make this modification because Kendall teaches that these vaccines are effective means for treating these diseases. See abstract, [0185], [0204], and [0301] of Kendall.
With regards to claim 10, the dissolvable microneedle patch of Alary and Joshi teaches the claimed invention of claim 1, however Alary is silent with regards to wherein the immune stimulating protein is Candida antigen.
Nonetheless Kendall, which is within the analogous art of delivery devices (see abstract and title), teaches wherein the immune stimulating protein is Candida antigen (see [0302] “Candida spp.,…candida fungal antigen components”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the therapeutically active ingredient of the dissolvable microneedle patch of Alary and Joshi in view of a teaching of Kendall such that the immune stimulating protein is Candida antigen. One of ordinary skill in the art would have been motivated to make this modification because Kendall teaches that the Candida fungal antigen component can be used to treat fungal infections. See [0302] of Kendall.
The dissolvable microneedle patch of Alary and Joshi modified in view of a teaching of Kendall will hereinafter be referred to as the dissolvable microneedle patch of Alary, Joshi, and Kendall.
With regards to claim 12, the dissolvable microneedle patch of Alary, Joshi, and Kendall teaches the claimed invention of claim 10 (see the 35 U.S.C. § 112(b) and 112(d) rejections above wherein Claim 12 is interpreted to be dependent upon Claim 10), and the dissolvable microneedle patch of Alary, Joshi, and Kendall further teaches wherein the Candida antigen is lyophilized (the Examiner notes that the recitation of “the Candida antigen is lyophilized” is a product-by-process limitation; even through product-by-process claims are limited by and defined by the process, determination is based on the product itself. MPEP 2113. Therefore even though Kendall is silent with regards to the process used to process the Candida antigen, the modified dissolvable microneedle patch of Alary, Joshi, and Kendall would be the same or similar to the claimed device, especially because both the Applicant’s apparatus and the prior art apparatus are both dissolvable microneedles to administer the therapeutically active ingredient.).
With regards to claim 14, the dissolvable microneedle patch of Alary and Joshi teaches the claimed invention of claim 1, however Alary is silent with regards to 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.
Nonetheless Kendall, which is within the analogous art of delivery devices (see abstract and title), teaches the immune stimulating protein selected from the group consisting of Candida antigen (see [0302] “Candida spp.,…candida fungal antigen components”), trichophyton antigen (see [0302] “Trichophyton spp.,”), tuberculin, purified protein derivative, human papillomavirus surface proteins (see [0298] “human papillomavirus proteins” and [0301] “papillomavirus”), interferon alpha, interferon beta, and interferon gamma.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the therapeutically active ingredient of the dissolvable microneedle patch of Alary and Joshi in view of a teaching of Kendall such that the immune stimulating protein is selected from the group consisting of Candida antigen, trichophyton antigen, and human papillomavirus surface proteins. One of ordinary skill in the art would have been motivated to make this modification because Kendall teaches that these immune stimulating proteins are effective means for treating these diseases. See abstract, [0185], [0204], and [0301] of Kendall.
With regards to claim 27, the dissolvable microneedle patch of Alary and Joshi teaches the claimed invention of claim 1, however Alary is silent with regards to wherein the microneedle patch administers to a subject in need thereof a therapeutically effective amount of Candida antigen.
Nonetheless Kendall, which is within the analogous art of delivery devices (see abstract and title), teaches the microneedle patch (100) (see [0182]) administers to a subject (see [0184]) in need thereof a therapeutically effective amount of Candida antigen (see [0302] “Candida spp.,…candida fungal antigen components”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the dissolvable microneedle patch of Alary and Joshi in view of a teaching of Kendall such that the microneedle patch administers to a subject in need thereof a therapeutically effective amount of Candida antigen. One of ordinary skill in the art would have been motivated to make this modification because Kendall teaches that the Candida fungal antigen component can be used to treat fungal infections. See [0302] of Kendall.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alary and Joshi as applied to claim 1 above, and further in view of Evans et al. (US 2007/0275045 A1) (hereinafter referred to as “Evans”).
With regards to claim 9, the dissolvable microneedle patch of Alary and Joshi teaches the claimed invention of claim 1, however Alary is silent with regards to wherein the immune stimulating molecule is imiquimod.
Nonetheless Evans, which is within the analogous art of composition for the treatment of warts (see abstract and title), teaches the immune stimulating molecule is imiquimod (see [0009], [0013] and [0143]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the therapeutically active ingredient of the dissolvable microneedle patch of Alary and Joshi in view of a teaching of Evans such that the immune stimulating molecule is imiquimod. One of ordinary skill in the art would have been motivated to make this modification because Evans teaches that imiquimod is a well-known treatment of common warts and molluscum contagiosum. See [0009], [0013], and [0143] of Evans.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alary and Joshi as applied to claim 1 above, and further in view of Chiang et al. (US 2016/0120799 A1) (hereinafter referred to as “Chiang”).
With regards to claim 13, the dissolvable microneedle patch of Alary and Joshi teaches the claimed invention of claim 1, however Alary is silent with regards to wherein the immune stimulating organism is selected from the group consisting of Propionbacterium Cutibacterium acnes, Corynebacterium parvum, Priopionobacterium, and Mycobacterium indicus pranii.
Nonetheless Chiang, which is within the analogous art of methods of using microneedle vaccine formulations to elicit animals protective immunity (see abstract and title), teaches the immune stimulating organism is selected from the group consisting of Propionbacterium Cutibacterium acnes, Corynebacterium parvum (see [0033] “Corynebacterium parvum”), Priopionobacterium, and Mycobacterium indicus pranii.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the therapeutically active ingredient of the dissolvable microneedle patch of Alary and Joshi in view of a teaching of Chiang such that the immune stimulating organism is Corynebacterium parvum. One of ordinary skill in the art would have been motivated to make this modification because Chiang teaches that Corynebacterium parvum can be added to a vaccine to increase a vaccine’s immunogenicity and enhance the immune response by slowly releasing the antigen. See [0033] of Chiang.
Claim(s) 17 – 20 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alary and Joshi as applied to claims 1 and 29 above, and further in view of Cantor (US 2008/0009811 A1).
With regards to claim 17, the dissolvable microneedle patch of Alary and Joshi teaches the claimed invention of claim 1, however Alary is silent with regards to wherein the plurality of microneedles are configured to have a sustained release of therapeutically active ingredient into the skin.
Nonetheless Cantor, which is within the analogous art of microneedle array applicators (see abstract and title), teaches the plurality of microneedles (240) (see [0022]) are configured to have a sustained release of therapeutically active ingredient into the skin (see [0041] “sustained release of drug”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of microneedles of the dissolvable microneedle patch of Alary and Joshi in view of a teaching of Cantor such that the plurality of microneedles are configured to have a sustained release of therapeutically active ingredient into the skin. One of ordinary skill in the art would have been motivated to make this modification because Cantor teaches that it is useful to configure the microneedle array for different types of delivery rates as needed such as sustained release or alternatively for immediate delivery depending on the application. See [0041] of Cantor.
The dissolvable microneedle patch of Alary and Joshi modified in view of a teaching of Cantor will hereinafter be referred to as the dissolvable microneedle patch of Alary, Joshi, and Cantor.
With regards to claim 18, the dissolvable microneedle patch of Alary, Joshi, and Cantor teaches the claimed invention of claim 17, however Alary is silent with regards to 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.
Nonetheless Cantor, which is within the analogous art of microneedle array applicators (see abstract and title), further teaches the plurality of microneedles (240) (see [0022]) 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 (see [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of microneedles of the dissolvable microneedle patch of Alary, Joshi, and Cantor in view of a further teaching of Cantor such that 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. One of ordinary skill in the art would have been motivated to make this modification because Cantor teaches that it is useful to configure the microneedle array for different types of delivery rates as needed such as sustained release or alternatively for immediate delivery depending on the application. See [0041] of Cantor.
With regards to claim 19, the dissolvable microneedle patch of Alary and Joshi teaches the claimed invention of claim 1, however Alary is silent with regards to wherein the plurality of microneedles are configured to have an immediate release of therapeutically active ingredient into the skin.
Nonetheless Cantor, which is within the analogous art of microneedle array applicators (see abstract and title), teaches the plurality of microneedles (240) (see [0022]) are configured to have an immediate release of therapeutically active ingredient into the skin (see [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of microneedles of the dissolvable patch of Alary and Joshi in view of a teaching of Cantor such that the plurality of microneedles are configured to have an immediate release of therapeutically active ingredient into the skin. One of ordinary skill in the art would have been motivated to make this modification because Cantor teaches that it is useful to configure the microneedle array for different types of delivery rates as needed such as sustained release or alternatively for immediate delivery depending on the application. See [0041] of Cantor.
The dissolvable microneedle patch of Alary and Joshi modified in view of a teaching of Cantor will hereinafter be referred to as the dissolvable microneedle patch of Alary, Joshi, and Cantor.
With regards to claim 20, the dissolvable microneedle patch of Alary, Joshi, and Cantor teaches the claimed invention of claim 19, however Alary is silent with regards to the plurality of microneedles 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.
Nonetheless Cantor, which is within the analogous art of microneedle array applicators (see abstract and title), teaches the plurality of microneedles 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 (see [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of microneedles of the dissolvable microneedle patch of Alary, Joshi, and Cantor in view of a further teaching of Cantor such that the plurality of microneedles 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. One of ordinary skill in the art would have been motivated to make this modification because Cantor teaches that it is useful to configure the microneedle array for different types of delivery rates as needed such as sustained release or alternatively for immediate delivery depending on the application. See [0041] of Cantor.
With regards to claim 33, the method of Alary and Joshi teaches the claimed invention of claim 29, however, Alary is silent with regards to wherein the biodegradable polymer degrades and releases therapeutically active ingredient into the skin over a period of about 1 day to about 30 days.
Nonetheless Cantor, which is within the analogous art of microneedle array applicators (see abstract and title), teaches the biodegradable polymer degrades and releases therapeutically active ingredient into the skin over a period of about 1 day to about 30 days (see [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the biodegradable polymer of the dissolvable microneedle patch of the method of Alary and Joshi in view of a teaching of Cantor such that the biodegradable polymer degrades and releases therapeutically active ingredient into the skin over a period of about 1 day to about 30 days. One of ordinary skill in the art would have been motivated to make this modification because Cantor teaches that it is useful to configure the microneedle array for different types of delivery rates as needed such as sustained release or alternatively for immediate delivery depending on the application. See [0041] of Cantor.
Claim(s) 21, 25, 30, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alary and Joshi as applied to claims 1 and 29 above, and further in view of Lee et al. (US 2009/0182306 A1) (hereinafter referred to as “Lee”).
With regards to claim 21, the dissolvable microneedle patch of Alary and Joshi teaches the claimed invention of claim 1 however, Alary is silent with regards to wherein the plurality of microneedles are configured to have both sustained release and an immediate release of therapeutically active ingredient into the skin.
Nonetheless Lee, which is within the analogous art of microneedle devices and methods of drug delivery (see abstract and title), teaches the plurality of microneedles are configured to have both sustained release and an immediate release of therapeutically active ingredient into the skin (see [0080] “sustained release of drug molecules or for both the rapid release and sustained release of drug molecules”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of microneedles of the dissolvable microneedle patch of Alary and Joshi in view of a teaching of Lee such that the plurality of microneedles are configured to have both sustained release and an immediate release of therapeutically active ingredient into the skin. One of ordinary skill in the art would have been motivated to make this modification because Lee teaches it is desirable to configure microneedles such that they provide both immediate drug release and sustained drug release. See [0080] of Lee.
With regards to claim 25, the dissolvable microneedle patch of Alary and Joshi teaches the claimed invention of claim 1 however, Alary is silent with regards to wherein the removable substrate comprises a therapeutically active ingredient dispersed in a polymer.
Nonetheless Lee, which is within the analogous art of microneedle devices and methods of drug delivery (see abstract and title), teaches the removable substrate comprises a therapeutically active ingredient dispersed in a polymer (see [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the removable substrate of the microneedle patch of Alary and Joshi in view of a teaching of Lee such that the removable substrate comprises a therapeutically active ingredient dispersed in a polymer. One of ordinary skill in the art would have been motivated to make this modification because Lee teaches that providing the removable substrate with a therapeutically active ingredient dispersed in a polymer provides for the sustained or maintenance dosing of the same drug that is immediately released through the microneedles. See [0036] of Lee.
With regards to claim 30, the method of Alary and Joshi teaches the claimed invention of claim 29, however, Alary is silent with regards to wherein at least 90% of the plurality of microneedles detach from the removable substrate within about 20 minutes after application of the dissolvable microneedle patch.
Nonetheless Lee, which is within the analogous art of microneedle devices and methods of drug delivery (see abstract and title) wherein at least 90% of the plurality of microneedles detach from the removable substrate within about 20 minutes after application of the dissolvable microneedle patch (see [0015], [0041] “less than 5 minutes,” [0088], and [0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of microneedles of the dissolvable microneedle patch of the method of Alary and Joshi in view of a teaching of Lee such that wherein at least 90% of the plurality of microneedles detach from the removable substrate within about 20 minutes after application of the dissolvable microneedle patch. One of ordinary skill in the art would have been motivated to make this modification because Lee teaches that this time range provides a rapid transport pathway for the drugs to pass into the biological barrier. See [0015] and [0041] of Lee.
With regards to claim 31, the method of Alary and Joshi teaches the claimed invention of claim 29, however, Alary is silent with regards to wherein at least 90% of the microneedles detach from the adhesive surface of the substrate upon removal of the substrate within a period of 5 minutes.
Nonetheless Lee, which is within the analogous art of microneedle devices and methods of drug delivery (see abstract and title) wherein at least 90% of the microneedles detach from the adhesive surface of the substrate upon removal of the substrate within a period of 5 minutes (see [0015], [0041] “less than 5 minutes,” [0088], and [0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of microneedles of the dissolvable microneedle patch of the method of Alary and Joshi in view of a teaching of Lee such that wherein at least 90% of the microneedles detach from the adhesive surface of the substrate upon removal of the substrate within a period of 5 minutes. One of ordinary skill in the art would have been motivated to make this modification because Lee teaches that this time range provides a rapid transport pathway for the drugs to pass into the biological barrier. See [0015] and [0041] of Lee.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1, 10, 12, 14, 17 – 21, 25 – 27, and 29 – 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 8 – 12, 15 – 17, and 19 – 23 of U.S. Patent No. 12,005,220 B2 (hereinafter referred to as “Patent ’220”) in view of Alary.
With regards to claim 1, Claim 1 of Patent ’220 recites a dissolvable microneedle patch for delivery of a therapeutically active ingredient to the skin comprising:
a plurality of microneedles; and
a removable substrate;
wherein the plurality of microneedles are attached to the removable substrate;
wherein the plurality of microneedles comprise a tapered tip that extends away from the removable substrate;
wherein the plurality of microneedles comprise a biodegradable polymer and a therapeutically active ingredient dispersed in the biodegradable polymer; and
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 (see Col. 83, lines 18 – 21 of Patent ’220 wherein the Candida antigen, trichophyton antigen, and tuberculin are examples of immune stimulating proteins); and
wherein the therapeutically active ingredient is substantially free of glycerin (see Col. 83, lines 8 – 23 of Patent ’220).
However, Claim 1 of Patent ’220 is silent with regards to the following:
the plurality of microneedles being at least two different lengths.
Nonetheless Alary, which is within the analogous art of microneedle arrays and methods of making and using microneedle arrays (see abstract and title), teaches the plurality of microneedles being at least two different lengths (see [0032] “Microneedles 30 in microneedle array 10 of the invention may also be of a variety of lengths and geometries,” [0040], and see Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of microneedles of the dissolvable microneedle patch of Patent ’220 in view of a teaching of Alary such that the plurality of microneedles being at least two different lengths. One of ordinary skill in the art would have been motivated to make this modification because Alary teaches that manufacturing the plurality of microneedles of at least two different lengths allows for the plurality of microneedles to penetrate a desirable depth of the skin to deliver the therapeutic agent. See [0032], [0040] and Fig. 4 of Alary.
The dissolvable microneedle patch of Patent ’220 modified in view of a teaching of Alary will hereinafter be referred to as the dissolvable microneedle patch of Patent ’220 and Alary.
With regards to claim 10, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of claim 1, and Claim 1 of Patent ’220 further recites wherein the immune stimulating protein is Candida antigen (see Col. 83, lines 17 – 21 of Patent ’220).
With regards to claim 12, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of claim 1, and Claim 5 of Patent ’220 further recites wherein the Candida antigen is lyophilized (see Col. 83, lines 33 – 34 of Patent ’220).
With regards to claim 14, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of claim 1, and Claim 1 of Patent ’220 further recites 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 (see Col. 83, lines 17 – 21 of Patent ’220).
With regards to claim 17, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of claim 1, and Claim 8 of Patent ’220 further recites wherein the plurality of microneedles are configured to have a sustained release of therapeutically active ingredient into the skin (see Col. 83, lines 43 – 46 of Patent ’220).
With regards to claim 18, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of claim 17, and Claim 9 of Patent ’220 further recites 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 (see Col. 83, lines 47 – 50 of Patent ’220).
With regards to claim 19, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of claim 1, and Claim 10 of Patent ’220 further recites wherein the plurality of microneedles are configured to have an immediate release of therapeutically active ingredient into the skin (see Col. 83, lines 51 – 54 of Patent ’220).
With regards to claim 20, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of claim 19, and Claim 11 of Patent ’220 further recites 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 (see Col. 83, lines 55 – 59 of Patent ’220).
With regards to claim 21, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of claim 1, and Claim 12 of Patent ’220 further recites wherein the plurality of microneedles are configured to have both sustained release and an immediate release of therapeutically active ingredient into the skin (see Col. 83, lines 60 – 63 of Patent ’220).
With regards to claim 25, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of claim 1, and Claim 15 of Patent ’220 further recites wherein the removable substrate comprises a therapeutically active ingredient dispersed in a polymer (see Col. 84, lines 4 – 6 of Patent ’220).
With regards to claim 26, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of claim 1, and Claim 16 of Patent ’220 further recites wherein the removable substrate comprises an adhesive medical tape (see Col. 84, lines 7 – 9 of Patent ’220).
With regards to claim 27, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of claim 1, and Claim 17 of Patent ’220 further recites wherein the microneedle patch administers to a subject in need thereof a therapeutically effective amount of Candida antigen (see Col. 84, lines 10 – 13).
With regards to claim 29, Claim 19 of Patent ’220 recites a method of treating a skin condition comprising:
i) applying a dissolvable microneedle patch for delivery of a therapeutically active ingredient to the skin comprising:
a plurality of microneedles and a removable substrate;
wherein the plurality of microneedles are attached to the removable substrate;
wherein the plurality of microneedles comprise a tapered tip that extends away from the removal substrate; and
wherein the plurality of microneedles comprise a biodegradable polymer and a therapeutically active ingredient dispersed in the biodegradable polymer; and
wherein the active ingredient is selected from the group consisting of a vaccine, an immune stimulating molecule, an immune stimulating organism, and an immune stimulating protein (see Col. 84, lines 29 – 32 of Patent ’220 wherein the Candida antigen, trichophyton antigen, and tuberculin are examples of immune stimulating proteins);
wherein the active ingredient is substantially free of glycerin; and
ii) exerting sufficient force on the dissolvable microneedle patch to permit the microneedles to penetrate to a location selected from the group consisting of the epidermis, the dermis, and the papillary dermis; and
iii) allowing the plurality of microneedles to remain in the skin until the biodegradable polymer degrades.; and
iv) removing adhesive substrate from the patch composition (see Col. 84, lines 18 – 42 of Patent ’220).
However, Claim 19 of Patent ’220 is silent with regards to the following:
the plurality of microneedles being at least two different lengths.
Nonetheless Alary, which is within the analogous art of microneedle arrays and methods of making and using microneedle arrays (see abstract and title), teaches the plurality of microneedles being at least two different lengths (see [0032] “Microneedles 30 in microneedle array 10 of the invention may also be of a variety of lengths and geometries,” [0040], and see Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of microneedles of the dissolvable microneedle patch of the method of Patent ’220 in view of a teaching of Alary such that the plurality of microneedles being at least two different lengths. One of ordinary skill in the art would have been motivated to make this modification because Alary teaches that manufacturing the plurality of microneedles of at least two different lengths allows for the plurality of microneedles to penetrate a desirable depth of the skin to deliver the therapeutic agent. See [0032], [0040] and Fig. 4 of Alary.
The method of Patent ’220 modified in view of a teaching of Alary will hereinafter be referred to as the method of Patent ’220 and Alary.
With regards to claim 30, the method of Patent ’220 and Alary teaches the claimed invention of Claim 29, and Claim 20 of Patent ’220 further recites wherein at least 90% of the plurality of microneedles detach from the removable substrate within about 20 minutes after application of the dissolvable microneedle patch (see Col. 84, lines 43 – 46 of Patent ’220).
With regards to claim 31, the method of Patent ’220 and Alary teaches the claimed invention of Claim 29, and Claim 21 of Patent ’220 further recites wherein at least 90% of the microneedles detach from the adhesive surface of the substrate upon removal of the substrate within a period of 5 minutes (see Col. 84, lines 47 – 50 of Patent ’220).
With regards to claim 32, the method of Patent ’220 and Alary teaches the claimed invention of Claim 29, and Claim 22 of Patent ’220 further recites wherein the biodegradeable polymer degrades and releases therapeutically active ingredient into the skin (see Col. 84, lines 51 – 53 of Patent ’220).
With regards to claim 33, the method of Patent ’220 and Alary teaches the claimed invention of Claim 29, and Claim 23 of Patent ’220 further recites wherein the biodegradable polymer degrades and releases therapeutically active ingredient into the skin over a period of about 1 day to about 30 days (see Col. 84, lines 54 – 57 of Patent ’220).
Claim(s) 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over Patent ’220 and Alary in further view of Kendall.
With regards to claim 8, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of Claim 1, however, Patent ’220 is silent with regards to 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.
Nonetheless Kendall, which is within the analogous art of delivery devices (see abstract and title), teaches the vaccine is selected from the group consisting of the measles-mumps-rubella vaccine (see [0301] “measles, mumps, rubella”), mumps vaccine (see [0301] “mumps”), the human papillomavirus vaccine (see [0298] “human papillomavirus” and [0301] “papillomavirus”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the therapeutically active ingredient of the dissolvable microneedle patch of Patent ’220 and Alary in view of a teaching of Kendall such that the vaccine is selected from the group consisting of the measles-mumps-rubella vaccine, mumps vaccine, the human papillomavirus vaccine. One of ordinary skill in the art would have been motivated to make this modification because Kendall teaches that these vaccines are effective means for treating these diseases. See abstract, [0185], [0204], and [0301] of Kendall.
Claim(s) 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over Patent ’220 and Alary in further view of Evans.
With regards to claim 9, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of Claim 1, however, Patent ’220 is silent with regards to wherein the immune stimulating molecule is imiquimod.
Nonetheless Evans, which is within the analogous art of composition for the treatment of warts (see abstract and title), teaches the immune stimulating molecule is imiquimod (see [0009], [0013] and [0143]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the therapeutically active ingredient of the dissolvable microneedle patch of Patent ’220 and Alary in view of a teaching of Evans such that the immune stimulating molecule is imiquimod. One of ordinary skill in the art would have been motivated to make this modification because Evans teaches that imiquimod is a well known treatment of common warts and molluscum contagiosum. See [0009], [0013], and [0143] of Evans.
Claim(s) 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over Patent ’220 and Alary in further view of Chiang.
With regards to claim 13, the dissolvable microneedle patch of Patent ’220 and Alary teaches the claimed invention of Claim 1, however, Patent ’220 is silent with regards to wherein the immune stimulating organism is selected from the group consisting of Propionbacterium Cutibacterium acnes, Corynebacterium parvum, Priopionobacterium, and Mycobacterium indicus pranii.
Nonetheless Chiang, which is within the analogous art of methods of using microneedle vaccine formulations to elicit animals protective immunity (see abstract and title), teaches the immune stimulating organism is selected from the group consisting of Propionbacterium Cutibacterium acnes, Corynebacterium parvum (see [0033] “Corynebacterium parvum”), Priopionobacterium, and Mycobacterium indicus pranii.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the therapeutically active ingredient of the dissolvable microneedle patch of Patent ’220 and Alary in view of a teaching of Chiang such that the immune stimulating organism is Corynebacterium parvum. One of ordinary skill in the art would have been motivated to make this modification because Chiang teaches that Corynebacterium parvum can be added to a vaccine to increase a vaccine’s immunogenicity and enhance the immune response by slowly releasing the antigen. See [0033] of Chiang.
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
07/06/2026
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