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 .
Election/Restrictions
Applicants’ election of Group I (claims 1-2, 4, 7-8, 11, 14, 16-19, 23-24, 27 and 34-35) drawn to a microneedle, is acknowledged. The election was made without traverse.
As the requirement for restriction is deemed proper, it is maintained and hereby made FINAL.
Claims 47, 64 are hereby withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. The instant claims have been examined commensurate with the scope of the elected invention. Applicants timely responded to the restriction requirement in the reply filed 3/16/26.
Accordingly, claims 1-2, 4, 7-8, 11, 14, 16-19, 23-24, 27 and 34-35 are under current examination.
Status of Claims
No new claim set was filed in response to the Restriction/Election requirement.
Amended claims
Newly canceled claims
Newly added claims
Previously canceled claims
3, 5-6, 9-10, 12-13, 15, 20-22, 25-26, 28-33, 36, 39-46, 48-63
Instantly withdrawn claims
47, 64
Claims under instant examination
1-2, 4, 7-8, 11, 14, 16-19, 23-24, 27, 34-35
Information Disclosure Statement
The information disclosure statement filed 03/17/2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been fully considered, since NPL #7 was not legible. Applicant is required to provide copies of the missing references to be considered by the examiner.
Specification
The use of the terms Proleukin®, Sylatron, Whatman and Triton which are trade names or a marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112(b)
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 1-2, 4, 7-8, 11, 14, 16-19, 23-24, 27, 34-35 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.
Claims 1-2, 4, 7-8, 11, 14, 16-19, 23-24, 27, 34-35 are unclear in that claim 1 recites conflicting limitations. In lines 1-2, claim 1 states “a plurality of silk-fibroin-based microneedles”; in lines 2-4, claim 1 requires “said plurality of microneedles comprising a first microneedle…and a second microneedle” and in line 5, claim 1 indicates that both first and second microneedle do not have to comprise silk fibroin in view of the “and/or”, which goes against the interpretation of lines 1-4 in the claim, which requires both first and second microneedle to be “silk fibroin-based”. Therefore, the metes and the bounds of the claimed invention are indefinite.
Claim 23 contains the trademark/trade names: GEMZAR, ZELBORAF, TAFINLAR, MEKINIST, ADRIAMYCIN. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe products and, accordingly, the identification/description is indefinite.
Regarding claim 23, the phrase "for example" (or in this case, a Latin abbreviation which means for example) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term "substantially" in claim 24 (two occurrences) is a relative term, which renders the claim indefinite. The term "substantially" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 34, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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, 4, 7-8, 11, 14, 16, 18, 24, 27, 34-35 and 37-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DiSimone et al. (US 2018/0064920; published: 3/8/18; in IDS dated 3/17/26)
DiSimone is directed to polymeric microneedles (Title).
With regards to instant claims 1-2, 4, 8, 11, 14, 16, 18, 24, 27, 34-35 and 37-38, DiSimone teaches a microneedle device comprising a backing and a plurality of biocompatible microneedles having one or more of: (i) a curved, discontinuous, undercut, and/or perforated sidewall; (ii) a sidewall comprising a breakable support; and (iii) a cross-section that is non-circular and non-polygonal (Abstract, claims). As can be seen in the image below, the microneedle patch (i.e., device with 40 40 microneedles) comprises a base and a plurality of microneedles, wherein the microneedle comprises a breakable support in various positions (near the base, near the tip or in between the base and tip):
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(Fig. 1). DiSimone teaches that the substrate can be sufficiently flexible to conform to a surface upon contact with the surface, e.g., a tissue or an organ surface, while allowing the microneedles to penetrate the tissue to the desired depth [0072]. In one aspect, the flexible substrate comprises a silk fibroin film integrated with silk fibroin microneedles [0072]. DiSimone teaches that the microneedles are dissolvable (the base is part of the microneedle) [0098]. With regards to the therapeutic agents, DiSimone teaches exemplary agent include delivery of chemotherapeutics or vaccines for cancer (e.g., skin cancer – melanoma, basal cell carcinoma, inflammatory breast cancer) [0170] and that microneedle devices can be used for chemotherapy and immunochemotherapy applications as an alternative to or in addition to traditional topical chemotherapy approaches [0172]. DiSimone teaches multiple bioactive agents can be delivered in a single microneedle array which enables an immunochemotherapeutic approach based on the co-delivery of a cytotoxic agent (i.e., anti-cancer agent) with an immune stimulant (i.e., immunomodulatory agent) [0173]. Such local and systemic anti-tumor response is capable of rejecting tumor cells at the site of treatment and throughout the body [0173]. DiSimone teaches that the therapeutic agent comprises a protein therapeutic, a small molecule therapeutic, a vaccine antigen, or an antigenic fragment thereof [0174].
DiSimone also teaches that the therapeutic agent(s) can be loaded in just the tip or the tip and the base [0157, 0159]. With regards to the pharmacokinetic profile, DiSimone teaches that one composition could enable rapid burst release of the therapeutic, while the other composition could provide sustained release of the therapeutic out of the needle [0159]. DiSimone teaches wherein the therapeutic agent is released from the microneedles over a time period of about 1 minute to about 6 months, e.g., 3 days [0103]. DiSimone teaches that microneedles (base + tip) can be fabricated from a number of compositions such as polyethylene glycol, polyacrylic acid and polycaprolactone (i.e., polymeric material), wherein the backing and microneedle comprise the same material [0086, 0151, Fig. 8A-C].
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 7-8, 11, 14, 16-18, 24, 27, 34-35 and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over DiSimone et al. (US 2018/0064920; published: 3/8/18; in IDS dated 3/17/26), in view of Shen (WO 2018/140826; published: 8/2/18).
As noted in the anticipation rejection above DiSimone anticipates claims 1-2, 4, 7-8, 11, 14, 16, 18, 24, 27, 34-35 and 37-38 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over DiSimone for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
DiSimone is directed to polymeric microneedles (Title).
With regards to instant claims 1-2, 4, 8, 11, 14, 16, 18, 24, 27, 34-35 and 37-38, DiSimone teaches a microneedle device comprising a backing and a plurality of biocompatible microneedles having one or more of: (i) a curved, discontinuous, undercut, and/or perforated sidewall; (ii) a sidewall comprising a breakable support; and (iii) a cross-section that is non-circular and non-polygonal (Abstract, claims). As can be seen in the image below, the microneedle patch (i.e., device with 40 40 microneedles) comprises a base and a plurality of microneedles, wherein the microneedle comprises a breakable support in various positions (near the base, near the tip or in between the base and tip):
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(Fig. 1). DiSimone teaches that the substrate can be sufficiently flexible to conform to a surface upon contact with the surface, e.g., a tissue or an organ surface, while allowing the microneedles to penetrate the tissue to the desired depth [0072]. In one aspect, the flexible substrate comprises a silk fibroin film integrated with silk fibroin microneedles [0072]. DiSimone teaches that the microneedles are dissolvable (the base is part of the microneedle) [0098]. With regards to the therapeutic agents, DiSimone teaches exemplary agent include delivery of chemotherapeutics or vaccines for cancer (e.g., skin cancer – melanoma, basal cell carcinoma, inflammatory breast cancer) [0170] and that microneedle devices can be used for chemotherapy and immunochemotherapy applications as an alternative to or in addition to traditional topical chemotherapy approaches [0172]. DiSimone teaches multiple bioactive agents can be delivered in a single microneedle array which enables an immunochemotherapeutic approach based on the co-delivery of a cytotoxic agent (i.e., anti-cancer agent) with an immune stimulant (i.e., immunomodulatory agent) [0173]. Such local and systemic anti-tumor response is capable of rejecting tumor cells at the site of treatment and throughout the body [0173]. DiSimone teaches that the therapeutic agent comprises a protein therapeutic, a small molecule therapeutic, a vaccine antigen, or an antigenic fragment thereof [0174].
DiSimone also teaches that the therapeutic agent(s) can be loaded in just the tip or the tip and the base [0157, 0159]. With regards to the pharmacokinetic profile, DiSimone teaches that one composition could enable rapid burst release of the therapeutic, while the other composition could provide sustained release of the therapeutic out of the needle [0159]. DiSimone teaches wherein the therapeutic agent is released from the microneedles over a time period of about 1 minute to about 6 months, e.g., 3 days [0103]. DiSimone teaches that microneedles (base + tip) can be fabricated from a number of compositions such as polyethylene glycol, polyacrylic acid and polycaprolactone (i.e., polymeric material), wherein the backing and microneedle comprise the same material [0086, 0151, Fig. 8A-C].
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although DiSimone teaches wherein the therapeutic agent can be a combination of anti-cancer agents and immunomodulatory agents [0173], DiSimone does not specifically teach wherein the anti-cancer agent is an mRNA, as required by instant claim 17. However, this deficiency is cured by Shen.
Shen is directed to biocompatible core/shell compositions suitable for the delivery of mRNA molecules to mammalian cells, wherein the delivery of mRNA encodes one or more cancer- or tumor-specific antigens to a population of antigen presenting cells and is used as a therapeutic cancer vaccine [Abstract] and more specifically7, used for treating and/or ameliorating the symptoms of one or more cancers or tumors in an affected mammal [Field of the Invention]. It is noted that Shen also teaches combining with an immunomodulating agent [0028].
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute one anti-cancer agent for another, each of which is taught by the prior art to be useful for the same purpose (anti-cancer agent of DiSimone with the mRNA-based anti-cancer vaccine taught by Shen for the purpose of treating cancer), in order to form a third composition to be used for the very same purpose (See MPEP 2144.06). Alternatively, Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (anti-cancer agent of DiSimone + mRNA-based anti-cancer vaccine taught by Shen for the purpose of treating cancer), in order to form a third composition to be used for the very same purpose (See MPEP 2144.06-I).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claims 1-2, 4, 7-8, 11, 14, 16, 18-19, 23-24, 27, 34-35 and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over DiSimone et al. (US 2018/0064920; published: 3/8/18; in IDS dated 3/17/26), in view of Gomez-Navarro (WO 2007/113648; published: 10/11/07).
As noted in the anticipation rejection above DiSimone anticipates claims 1-2, 4, 7-8, 11, 14, 16, 18, 24, 27, 34-35 and 37-38 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over DiSimone for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
DiSimone is directed to polymeric microneedles (Title).
With regards to instant claims 1-2, 4, 8, 11, 14, 16, 18, 24, 27, 34-35 and 37-38, DiSimone teaches a microneedle device comprising a backing and a plurality of biocompatible microneedles having one or more of: (i) a curved, discontinuous, undercut, and/or perforated sidewall; (ii) a sidewall comprising a breakable support; and (iii) a cross-section that is non-circular and non-polygonal (Abstract, claims). As can be seen in the image below, the microneedle patch (i.e., device with 40 40 microneedles) comprises a base and a plurality of microneedles, wherein the microneedle comprises a breakable support in various positions (near the base, near the tip or in between the base and tip):
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688
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(Fig. 1). DiSimone teaches that the substrate can be sufficiently flexible to conform to a surface upon contact with the surface, e.g., a tissue or an organ surface, while allowing the microneedles to penetrate the tissue to the desired depth [0072]. In one aspect, the flexible substrate comprises a silk fibroin film integrated with silk fibroin microneedles [0072]. DiSimone teaches that the microneedles are dissolvable (the base is part of the microneedle) [0098]. With regards to the therapeutic agents, DiSimone teaches exemplary agent include delivery of chemotherapeutics or vaccines for cancer (e.g., skin cancer – melanoma, basal cell carcinoma, inflammatory breast cancer) [0170] and that microneedle devices can be used for chemotherapy and immunochemotherapy applications as an alternative to or in addition to traditional topical chemotherapy approaches [0172]. DiSimone teaches multiple bioactive agents can be delivered in a single microneedle array which enables an immunochemotherapeutic approach based on the co-delivery of a cytotoxic agent (i.e., anti-cancer agent) with an immune stimulant (i.e., immunomodulatory agent) [0173]. Such local and systemic anti-tumor response is capable of rejecting tumor cells at the site of treatment and throughout the body [0173]. DiSimone teaches that the therapeutic agent comprises a protein therapeutic, a small molecule therapeutic, a vaccine antigen, or an antigenic fragment thereof [0174].
DiSimone also teaches that the therapeutic agent(s) can be loaded in just the tip or the tip and the base [0157, 0159]. With regards to the pharmacokinetic profile, DiSimone teaches that one composition could enable rapid burst release of the therapeutic, while the other composition could provide sustained release of the therapeutic out of the needle [0159]. DiSimone teaches wherein the therapeutic agent is released from the microneedles over a time period of about 1 minute to about 6 months, e.g., 3 days [0103]. DiSimone teaches that microneedles (base + tip) can be fabricated from a number of compositions such as polyethylene glycol, polyacrylic acid and polycaprolactone (i.e., polymeric material), wherein the backing and microneedle comprise the same material [0086, 0151, Fig. 8A-C].
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although DiSimone teaches wherein the therapeutic agent can be a combination of anti-cancer agents and immunomodulatory agents [0173], DiSimone does not specifically teach wherein microneedle device is configured to administer an anti-PD1 antibody and/or an anti-CTLA4 antibody in combination with, for example, gemcitabine or a cytokine (e.g., IL-2, IL-12 or IL-15), as required by instant claims 19 and 23. However, this deficiency is cured by Gomez-Navarro.
Gomez-Navarro is directed to anti-CTLA4 antibody combination therapy for the treatment of cancer, wherein the second chemotherapeutic agent is for example, gemcitabine, for the treatment of pancreatic cancer [Abstract]. Gomez-Navarro teaches that the anti-CTLA4 antibody may also be administered with a cytokine such as IL-2, IL-12, IL-15 or IL-18, IFNɑ, IFNβ, IFNƔ, TNFɑ, TNFβGM-CSF or TGF-β [Section IV Therapeutic Agents].
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute one anti-cancer agent for another, each of which is taught by the prior art to be useful for the same purpose (anti-cancer agent and immunomodulatory agent of DiSimone with the anti-CTLA4 antibody/cytokine or gemcitabine combination taught by Gomez-Navarro for the purpose of treating cancer), in order to form a third composition to be used for the very same purpose (See MPEP 2144.06). Alternatively, Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (anti-cancer agent and immunomodulatory agent of DiSimone + the anti-CTLA4 antibody/cytokine or gemcitabine combination taught by Gomez-Navarro for the purpose of treating cancer), in order to form a third composition to be used for the very same purpose (See MPEP 2144.06-I).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617
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