DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 01/05/2026 has been entered. Claims 1-4, 6-15, 17-18, 23, 28-35 are pending in the application. Claims 17-18, 23, 28-35 are withdrawn as they are drawn to a nonelected invention.
Response to Arguments
Applicant’s arguments filed 01/05/2025, on pages 8-11, regarding the Office Action mapping both the activation particle and the therapeutic payload as complementary molecule 171 of Pushpala have been fully considered and are persuasive. A new ground of rejection that no longer relies on Pushpala is detailed below.
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.
Claim 13 is 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 13 recites the limitation “a first therapeutic agent and a second embedded”. It is unclear if the “second” is refereeing to a second therapeutic agent or a second of another element. For the sake of examination, the limitation will be interpreted as reciting “a first therapeutic agent and a second therapeutic agent embedded”.
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, 6-7, 9-10, 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yan (US 2014/0142541).
Regarding Claim 1, Yan discloses a microneedle therapeutic payload delivery device (device of Fig 1), comprising: a substrate (“base”); an activation particle (“nanomaterial”); and one or more degradable microneedle structures (“microneedles”) coupled to the substrate and including a polymeric matrix (“dissolvable polymer”) structured to embed the activation microparticle and one or more therapeutic payloads (“drug or biomolecule”) (Para 0023-0024, 0032), the one or more degradable microneedle structures each including an exterior wall spanning outward from a base surface and forming an apex at a terminus point of the exterior wall (See step 9 of Fig 1 showing the exterior wall of the microneedle spanning outward from a base and it apex or point), wherein the polymeric matrix of a microneedle structure of the one or more degradable microneedle structures is degradable under an environmental parameter of a biofluid surrounding the microneedle structure to dissolve and allow the one or more therapeutic payloads and the activation particle to the surrounding biofluid (Para 0027, 0032).
Regarding Claim 2, Yan discloses the activation particle is configured to react with biofluid to enhance transport of the one or more therapeutic payloads into a tissue by dispersion of the one or more therapeutic payloads away from the one or more degradable microneedle structures and penetration of the one or more therapeutic payloads deeper into the tissue (Para 0045, the nanomaterial “allows the microneedles to deliver drugs or biomolecules effectively that may otherwise not be able to enter cells”).
Regarding Claim 4, Yan discloses the activation particle includes magnesium microparticles (Para 0026).
Regarding Claim 6, Yan discloses the activation particle is a chemically modified microparticle or nanoparticle with at least one of biocatalytic enzymes, an inorganic material (Para 0026), or a microparticle or nanoparticle modified metal organic frameworks (MOF).
Regarding Claim 7, Yan discloses the polymeric matrix is formed of a transient degradable material including one or more of polyvinylpyrrolidone (PVP), carboxymethylcellulose (CMC) (Para 0028), hyaluronic acid (HA), sodium alginate (SA), or Pullulan.
Regarding Claim 9, Yan discloses the one or more therapeutic payloads includes a therapeutic agent selected from the group consisting of immune oncology agents, chemotherapeutic agents, chronic pain agents, cardiovascular agents, anti-aging agents, antiviral agents, vaccines (Para 0004), antibacterial agents, micronutrients, and gene editing effectors, and/or wherein the one or more therapeutic payloads includes a nanoparticle to which the therapeutic agent is attached.
Regarding Claim 10, Yan discloses the one or more therapeutic payloads includes one or more of a drug, particle, molecule, genetic material, protein, virus-like particle, virus, enzyme, nanoparticle, or combination thereof (Para 0004).
Regarding Claim 13, Yan discloses the one or more therapeutic payloads includes a first therapeutic agent and a second therapeutic agent embedded within at least one microneedle structure of the one or more degradable microneedle structures (Para 0032; the language says at least one drug and thus two drugs in the microneedles is considered).
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yan (US 2014/0142541) as evidenced by Ghartey-Tagoe (US 2015/0079133).
Regarding Claim 15, Yan discloses the environmental parameter includes a pH of less than 7.0 (Para 0027) (Ghartey-Tagoe teaches that the epithelium of the skin has a pH of 4.5).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Yan (US 2014/0142541) in view of Engqvist (US 2013/0273119).
Regarding Claim 3, Yan discloses the activation particle is microparticle or nanoparticle (Para 0026) , however, is silent regarding wherein the activation particle is coated with an enteric polymer.
Engqvist teaches a transdermal drug administration device wherein the particles are coated with an enteric coating in order to provide a delayed-release of the particle (Para 0072-0074).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the activation particle to be coated with an enteric polymer as taught by Engqvist in order to prevent or minimize release of the active ingredient until it has reached the target tissue (Para 0074).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yan (US 2014/0142541) in view of Traverso (US 2013/0165772).
Regarding Claim 8, Yan discloses all of the elements of the invention as discussed above, however, is silent regarding one or more passive microneedle structures coupled to the substrate and including a nondegradable material, the one or more passive microneedle structures each including an external wall spanning outward from a base surface and forming an apex at a terminus point of the external wall.
Traverso teaches a microneedle device having one or more passive microneedle structures coupled to the substrate and including a nondegradable material, the one or more passive microneedle structures each including an external wall spanning outward from a base surface and forming an apex at a terminus point of the external wall (Para 0016).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microneedle structures to have a mixture of degradable and nondegradable microneedles as taught by Traverso in order to perform different purposes with the same device (i.e. therapeutic delivery and diagnostics) (Para 0051).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yan (US 2014/0142541) in view of Alary (US 2018/0177990).
Regarding Claim 11, Yan discloses the one or more therapeutic payloads includes a first therapeutic agent embedded within a first microneedle structure of the one or more degradable microneedle structures (Para 0032), however, is silent regarding a second therapeutic agent embedded within a second microneedle structure of the one or more degradable microneedle structures.
Alary discloses an analogous microneedle therapeutic payload delivery device (10, Fig 1) comprising a first therapeutic agent embedded within a first microneedle structure (30a, Fig 2) of the one or more degradable microneedle structures (Para 0029), and a second therapeutic agent embedded within a second microneedle structure (30b, Fig 2) of the one or more degradable microneedle structures (Para 0029).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microneedle structures to have a first therapeutic agent and a second therapeutic agent as taught by Alary in order to simultaneously delivery more than one therapeutic agent in a simple, effective, and economical way (Para 0010).
Regarding Claim 12,the modified invention of Yan and Alary discloses the first therapeutic agent is releasable into the biofluid surrounding the microneedle structure before a release of the second therapeutic agent (Para 0052 -Alary; differing release rates results in one agent being releasable before the other agent).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Yan (US 2014/0142541) in view of Jung (US 2020/0016388).
Regarding Claim 14, Yan discloses all of the elements of the invention as discussed above, however, is silent regarding the substrate includes an adhesive material on at least a side of the substrate interfaced with the one or more degradable microneedle structures.
Jung teaches an analogous microneedle therapeutic payload delivery device wherein the substrate (100, Fig 1) includes an adhesive material on at least a side of the substrate interfaced with the one or more degradable microneedle structures (Para 0094).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the substrate to include an adhesive material in order to easily attach the delivery device to a human body (Para 0094).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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