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 .
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 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.
Election/Restrictions
Applicant’s election without traverse of Group I, the particle or kit of claim 1, and the composition recited in claim 33, reading on claims 1, 3-5, 8, 9, 11, 12, 15, 17, 19, 21, 22, 41, and 42, in the response dated 4/14/2026, is acknowledged.
Claims 23, 26, and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Status
Claims 2, 6-7, 10, 13-14, 16, 18, 20, 24-25, 27-32, and 35-40 are cancelled.
Claims 41-44 are newly added.
Claims 1, 3-5, 8-9, 11-12, 15, 17, 19, 21-23, 26, 33, and 41-44 are pending.
Claims 23, 26, and 43 are withdrawn.
Claims 1, 3-5, 8-9, 11-12, 15, 17, 19, 21-22, 33, 41-42, and 44 are examined on the merits in this prosecution. Claim 44 has been added to the examined claims, in addition to the claims set forth on page 10 of Applicant Argument dated 4/14/2026.
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CLAIM REJECTIONS
Indefiniteness Rejection
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.
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, or for pre-AIA the applicant regards as the invention.
Claim 12 recites the term “wherein the payload is stable after a short-term or a long-term exposure to high temperature,” followed by optional temperatures and optional times of payload exposure. Since the claim does not set specific metes and bounds for the terms “short-term,” “long-term,” and “high temperature,” the claim is considered indefinite.
Obviousness Rejection
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.
1) Claims 1, 3-5, 8, 9, 11-12, 15, 17, 19, 21-22, 33, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Ostroff (US 2012/0070376 A1, cited in IDS dated 1/3/2025), in view of Poinard (“Polydopamine Coating Enhances Mucopenetration and Cell Uptake of Nanoparticles,” ACS Appl. Mater. Interfaces 2019, 11, 4777-4789).
For claim 1, Ostroff teaches a yeast cell wall particle loaded with mesoporous silica nanoparticles (Abstract; pg 3, [0026]). The yeast cell wall particles can encapsulate the nanoparticles within the inner cavity of the hollow yeast cell wall particle and the nanoparticles can be loaded with one or more soluble payloads, including DNA, siRNA, protein, and small molecules (pg 7, [0079]). The Examiner considers the phrase "loaded with one or more soluble payloads" to read on the substantially or completely encapsulated by a nano-silica cage" limitation of the instant claim. Ostroff also teaches (pg 7, [0076]).:
Glucan particles (GPs), also referred to herein as yeast glucan particles ("YGPs"), are a purified hollow yeast cell 'ghost' containing rich ~-glucan sphere, generally 2-4 microns in diameter. In general, glucan particles can be prepared from yeast cells by the extraction and purification of the alkali-insoluble glucan fraction from the yeast cell walls.
Regarding the claim 1 limitation of “gastric resistant,” Ostroff teaches the following (pg 16, [0171]):
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Regarding the claim 1 limitation of “the YP surface is further modified to display a receptor ligand,” Ostroff teaches the following (pg 2, [0010]): “Nanoparticles can be somewhat targeted by attaching ligands with specificity to receptors that are overexpressed in certain cells.”
For claim 3, Ostroff teaches yeast cell wall particles and yeast glucan particles ([0076], [0079]).
For claim 4, Ostroff teaches the nano-silica yeast particle can be loaded with one or more soluble payloads, including DNA, siRNA, protein, and small molecules ([0079]).
For claim 5, Ostroff teaches the mesoporous silica nanoparticles with the ability to trap chemotherapeutic drugs may contain tetraethoxyorthosilicate (TEOS) and amino-propyltriethoxysilane (APTS) (pg 21, [0207]).
For claims 8, 9, 11, and 19, Ostroff teaches the coating polymers of the instant specification at ¶ [0171], reproduced, in part, supra.
For claim 12, Ostroff teaches stability of the nanoparticle over 48 hours at room temperature (pg 23, [0224]).
For claim 15, Ostroff teaches one or payloads, wherein the term payload refers to a substance such as a small molecule or biomolecule, a protein, a peptide, and/or a nucleic acid (pg 3, [0025], [0030]; pg 5, [0059]).
For claims 21 and 22, Ostroff teaches (pg 14, [0166]):
a kit may comprise two separate pharmaceutical compositions comprising respectively a first composition comprising a particulate delivery system and a pharmaceutically acceptable carrier; and composition comprising second pharmaceutically active compound and a pharmaceutically acceptable carrier. The kit also comprises a container for the separate compositions, such as a divided bottle or a divided foil packet. Additional examples of containers include syringes, boxes, bags, and the like. Typically, a kit comprises directions for the administration of the separate components. The kit form is particularly advantageous when the separate components are preferably administered in different dosage forms (e.g., oral and parenteral), are administered at different dosage intervals, or when titration of the individual components of the combination is desired by the prescribing physician
For claim 41, Ostroff teaches
payloads encapsulated inside the glucan particles can be prepared by first introducing payload molecules into the glucan particle to form a core. In some embodiments, the core can be made of nucleic acids such as DNA or RNA, proteins or peptides, natural or synthetic molecules and/or polymers, inorganic complexes and other synthetic, organic, inorganic or biological particles. The payload molecules can then be coated with a payload trapping molecule to
result in a polyplexed payload.
See pg 9, [0099]).
As such, one of ordinary skill has the ability to determine the degree of encapsulation, up to 100%, to obtain the controlled release characteristics desired (pg 9, [0100]).
Ostroff does not teach the claim 1 limitation of a YP surface modified with a mucus penetrating layer.
Poinard teaches the missing element of Ostroff.
Poinard teaches mucus is an endogenous biopolymer barrier that limits the entry of foreign pathogens and therapeutic carriers to the underlying mucosa! cells. Poinard teaches a polydoparnine (PDA) coating enhances both the mucopenetration and cell uptake of nanoparticles (Abstract; pg 4778, left column, first full paragraph). Poinard also teaches that PDA has been used for coating medical implants and as a drug carrier, and is known to be biocompatible and has a minimal immune response (pg 4778, left column, second full paragraph).
For claims 33 and 44, each limitation is taught by the combination of Ostroff and Poinard, as described above.
For claim 42, Poinard teaches a polydoparnine (PDA) coating (Abstract; pg 4778, left column, first full paragraph)
The skilled artisan would have expected success in utilizing polydopamine as a mucus-penetrating layer on the YP surface of the nanoparticle of Ostroff since Poinard teaches a polydoparnine coating enhances both the mucopenetration and cell uptake of nanoparticles, and polydopamine is known in the art a being non-toxic and of low immunogenicity.
2) Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ostroff (cited above), in view of Poinard (cited above) and Fahmy (US 2016/0303052 A1).
The teachings of Ostroff and Poinard are discussed above.
The combination of Ostroff an Poinard does not teach the limitation of a YP a receptor ligand displaying the arginylglycylaspartic acid (RGD) peptide.
Fahmy teaches the missing element of the combination of Ostroff an Poinard.
Fahmy teaches a nanoparticulate composition comprising an immunomodulator and a second active agent enclosed within a delivery vehicle, wherein the delivery vehicle is a biodegradable polymeric nanoparticle (pg 32, claim 1). Fahmy teaches that the nanoparticle comprises a targeting moiety such as an RGD peptide (pg 32, claims 10 and 13).
The skilled artisan would have expected success in utilizing polydopamine as a mucus-penetrating layer on the YP surface of the nanoparticle of the combination of Ostroff and Poinard since Fahmy teaches an RGD targeting moiety can be added to polymeric nanoparticles to improve delivery of the nanoparticle to a target cell (Abstract).
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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