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 .
Status of the Claims
Claims 1, 3-5, 8, 11, 12, 14, 15, 17-19, 21-23, 25-27, 29, and 30 are pending and under current examination.
Withdrawn Claim Objections and Rejections
All objections to claim 15 are withdrawn in view of the amendments to the claims filed 1/26/2026.
All rejections under 112(a) for enablement and written description are withdrawn in view of the amendments to the claims filed 1/26/2026.
All rejections to claims 8 and 11 under 112(b) are withdrawn in view of the arguments and amendments to the claims filed 1/26/2026.
All rejections not reiterated have been withdrawn.
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 14 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.
The terms “short-term” and “long-term” in claim 12 are relative terms which render the claim indefinite. The terms “short-term” and “long-term” are 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. It is impossible to discern the length of time embraced by the instant claim, therefore the metes and bounds of the claim are indefinite.
Regarding claim 14, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Response to Arguments
Applicant's arguments filed 1/26/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with regard to the terms “the payload”, “high temperature”, and “stable” have been considered and are persuasive. Accordingly, the rejection of claims 12 and 14 over the terms “the payload”, “high temperature”, and “stable” has been withdrawn. However, the amendments and arguments do not address the indefiniteness concerns over the relative terms “short-term” and “long-term” in claim 12 and therefore the rejection over those terms has been maintained. Claim 14 is rejected for its dependency on claim 12.
Claim Rejections - 35 USC § 103
Applicant’s amendments to the claims filed 1/26/2026 have necessitated the new grounds of rejection.
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 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.
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, 3-5, 8, 11, 12, 14, 15, 17, 18, 23, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Ostroff (U.S. Patent Application No. 2012/0070376, publication date: 3/22/2012, cited in the IDS filed 1/3/2025, of record) in view of Chen et al. (Scientific Reports, pg. 1-8; publication year: 2017, cited in the IDS filed 1/3/2025).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 1, Ostroff teaches a yeast cell wall particle loaded with mesoporous silica nanoparticles [0026]. The yeast cell wall particles can encapsulate the nanoparticles within the inner cavity of the hollow yeast cell wall particle [0109]. The nanoparticles can be loaded with one or more soluble payloads. The soluble payload molecules can also be bound to or embedded in the nanoparticles of the invention [0030]. The payload may be a small molecule or biomolecules such as a protein, peptide or nucleic acid [0059].
Regarding claim 3, Ostroff teaches that exemplary yeast cell wall particles for the invention include yeast glucan particles, glucan particles, yeast chitosan particles, and yeast chitosan/mannan particles [0057].
Regarding claims 4 and 25, Ostroff teaches that the payload may be a small molecule or biomolecules such as a protein, peptide or nucleic acid [0059].
Regarding claim 5, Ostroff teaches that the mesoporous silica nanoparticle may be prepared from tetraethyl orthosilicate [0048].
Regarding claims 8 and 11, Ostroff teaches that preferred routes of administration of the particles are oral, pulmonary, intravenous and transdermal [0161]. Oral compositions of the invention may include enteric coated systems based on methacrylate copolymers such as poly(methacrylic acid) and methylmethacrylate) [0171] which are only soluble at pH 6 and above, so that the polymer only begins to dissolve on entry into the small intestine [0171].
Regarding claims 12 and 14, Ostroff teaches the relevant limitations as described above.
Regarding claim 15, Ostroff teaches that the yeast cell particles may include nanoparticles and one or more payloads [0026].
Regarding claim 17, Ostroff teaches that solid dosage formulation including the yeast particle delivery system may include an inert customary excipient or carrier [0170].
Regarding claim 18, Ostroff teaches that the yeast particle delivery system may be included in a kit comprising a pharmaceutical composition of the yeast particle delivery system and instructional material [0165].
Regarding claim 23, Ostroff teaches the relevant limitations as described for claim 1 above. Ostroff also teaches that the yeast particle delivery system may be administered as part of a pharmaceutically acceptable composition [0162].
Regarding claim 26, Ostroff teaches that the yeast particle delivery system may be administered as part of a pharmaceutically acceptable composition [0162] and that the nanoparticles of the invention can be used in a variety of pharmaceutical applications, for example treatment of diseases [0154].
Regarding claim 27 and 29-30, Ostroff teaches the relevant limitations as described above in the rejection of claim 1. Ostroff also teaches that the particulate delivery system is administered to a patient in a therapeutically effective amount [0162].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1, 5, 12, 14, 23, 27, 29, and 30, Ostroff does not teach that the nano-silica cage is a continuous, covalently bound silica matric in a mesh net form the conforms to the shape of the payload. However, this deficiency is cured by Chen.
Chen teaches the ensilication of proteins in a silica cage, rendering them stable against denaturing thermal treatment and long-term ambient temperature storage. This produces a storable solid protein-loading material without the need for desiccation or freeze-drying. Ensilication offers the prospect of a solution to the “cold chain” problem for biological materials, in particular for vaccines (pg. 1, Abstract) and can be valuable for the storage of industrial enzymes, vaccines, and biological therapeutics (pg. 5, Discussion). The ensilication method utilizes pre-hydrolyzed tetraethylorthosilicate (TEOS) to encapsulate proteins (pg. 2, Introduction), including the TTCF protein vaccine component (pg. 4, fifth paragraph), to form silica nanoparticles of 200nm in size (pg. 3, Introduction). The proteins are encased in a covalently bonded silica network (pg. 4, final paragraph). Chen also teaches that silica can be deposited around proteins and closely match their shape (pg. 1, Abstract).
Regarding claim 8, Ostroff does not teach that the coating polymer is in the hollow inner cavity of the yeast particle.
Regarding claims 12 and 14, Ostroff does not teach the stability of the payload under different time or temperature conditions. However, this deficiency is cured by Chen.
Chen teaches that the ensilicated proteins maintain enzymatic activity when stored for six months at 22oC or heated at 100oc for 5 hours (pg. 4, first paragraph).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1, 5, 12, 14, and 27, based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (the TEOS silica nanoparticles of Ostroff and the TEOS silica nanoparticles of Chen for the purpose of encapsulating proteins). See MPEP 2144.06 (II).
Regarding claim 8, it would have been prima facie obvious to one of ordinary skill in the art of filing to include a coating polymer in the hollow inner cavity of the yeast particle. One would have understood in view of Ostroff that an enteric coating system comprising a coating polymer that is only soluble at pH 6 and above only begins to dissolve on entry into the small intestine [0171]. It would have been obvious to include such a coating polymer on the nanoparticles house on the inside of the hollow inner cavity of the yeast particle. One of ordinary skill in the art of filing would have been motivated to include an enteric coating on the nanoparticles in order to prevent degradation of the nanoparticles, and therefore release of the payload, outside of the small intestine. The artisan of ordinary skill in the art of filing would have had reasonable expectation of success because Ostroff teaches that oral administration systems of the invention may include an enteric coating.
Claims 19, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Caras et. al. (Major Qualifying Project Report, Worcester Polytechnic Institute, available 4/28/2011, cited in the IDS filed 1/3/2025, of record) in view of Ostroff (U.S. Patent Application No. 2012/0070376, publication date: 3/22/2012, cited in the IDS filed 1/3/2025, of record) and Doekhie et. al. (Scientific Reports, pg. 9243; publication year: 2020, of record).
Applicant’s Invention
Applicants claim 19 is drawn to a method of preparing a nano-silica yeast particle (YP) delivery system comprising the steps of:(a) loading a YP comprising a hollow inner cavity with at least one first payload; and (b) resuspending the YP in prepolymerized tetrahydroorthosilicate (TEOS) in half hydrodynamic volume, wherein the prepolymerized TEOS is prepolymerized at a pH of about 2 to about 4, wherein the TEOS polymerizes to form a nano-silica cage within the hollow inner cavity, and wherein the nano-silica cage substantially or completely encapsulates the at least one first payload at an encapsulation efficiency of at least 90%, and wherein the nano-silica cage and the at least one first payload are both confined within the hollow inner cavity of the YP.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 19, Caras teaches a method of mesoporous silica nanoparticle synthesis inside glucan lipid particles comprising first mixing glucan lipid particles with tetramethyl orthosilicate (TEOS), ethanol, and geraniol and incubating a room temperature for 1 hour. The samples are centrifuged, the supernatant discarded, and the samples lyophilized. CTAB and NaOH solution are added followed by incubation to initiate polymerization of the TEOS (pg. 25, 2.4.1 MSN Synthesis with F-APTS and pg. 13, 1.2.1 Mesoporous Silica Nanoparticle Synthesis). The payload of water-soluble or insoluble drugs are dissolved in water or a water/DMSO mixture and incubated with the particle-MSN samples to uptake the drug (pg. 30, 2.6.2 Drug Binding to GLP-MSN). Caras also teaches that the synthesis of mesoporous silica nanoparticles can be performed in acidic or basic conditions and that manipulating temperature, micelle formation, co-solvent and pH during the process, the size and shape of the nanoparticles that are generated can be controlled (pg. 13, 1.2.1 Mesoporous Silica Nanoparticle Synthesis).
Regarding claims 21 and 22, Caras teaches the relevant limitations of claim 19 above.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claim 19, Caras does not disclose a prepolymerized TEOS, a hydrodynamic volume for the resuspension on the yeast particles, or an encapsulation efficiency. However, this deficiency is cured by Ostroff and Doekhie.
Ostroff teaches that the nanoparticle can be installed or encapsulated within the glucan particles using a pull-push mechanism to effectively encapsulated the nanoparticles with just inside the particle or all the way into the inner cavity of the particle [0115]. The dry glucan particle can be rehydrated to push the nanoparticle cargo inside the particle [0115]. Ostroff teaches that when loading payloads, including nanoparticle payloads, loading can be performed using subhydrodynamic volumes to facilitate the push-pull mechanism [0116]. Doekhie teaches that TEOS may be pre-hydrolyzed with 32% HCl prior to ensilication of recombinant protein in order to prepare a long-term storable product (pg. 2, Expression of recombinant TTCT in BL21(DE3) E. coli, ensilication and release).
Regarding claim 21, Caras does not teach the addition of one or more additional payloads in the yeast particle. However, this deficiency is cured by Ostroff.
Ostroff teaches that the yeast cell particles may include nanoparticles and one or more payloads [0026] and that multiplexed co-delivery of different payloads is possible [0072].
Regarding claim 22, Caras does not teach a step of loading a coating polymer in the yeast particle. However, this deficiency is cured by Ostroff.
Ostroff teaches that a trapping polymer may be added to facilitate encapsulation of the payload in the yeast particle [0117]. The trapping polymer may facilitate sustained release, protection of the payload, or other desired delivery property [0088].
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claim 19, it would have been prima facie obvious to one of ordinary skill in the art of filing to utilize the pre-hydrolyzed TEOS of Doekhie in the in situ ensilication taught by Caras. One would have understood in view of Doekhie that the pre-hydrolyzed TEOS aids in the formation of a long-term storable product (pg. 2, Expression of recombinant TTCF in BL21(DE3) E. coli, ensilication and release). One of ordinary skill in the art of filing would have been motivated to use the pre-hydrolyzed TEOS of Doekhie in order to lend increased storage stability to the nano-silica particles embraced by Caras. The artisan of ordinary skill would have had reasonable expectation of success because Doekhie teaches that pre-hydrolyzed TEOS may be used to ensilicate a protein for long term storage.
Furthermore, it would have been prima facie obvious to add the pre-polymerized TEOS to the yeast particle embraced by Caras at half hydrodynamic volume. One would have understood in view of Ostroff that when loading payloads, including nanoparticle payloads, loading can be performed using subhydrodynamic volumes to facilitate the push-pull mechanism [0116]. It would have been obvious to introduce pre-polymerized TEOS into the yeast particles at half hydrodynamic volume. One of ordinary skill in the art of filing would have been motivated to add pre-polymerized TEOS at half hydrodynamic volume in order to facilitate a push-pull mechanism to introduce the TEOS inside the glucan particle. The artisan of ordinary skill in the art of filing would have had reasonable expectation of success because Ostroff teaches that payloads may be introduced into glucan particles by using subhydrodynamic volumes to facilitate the push-pull mechanism.
With regard to the encapsulation efficiency of the nano-silica cage, although Caras does not disclose all the characteristics and properties of the composition disclosed in the present claims, based on the substantially identical process using identical components, the Examiner has a reasonable basis to believe that the properties claimed in the present invention are inherent in the composition disclosed by Caras. Because the PTO has no means to conduct analytical experiments, the burden of proof is shifted to the Applicant to prove that the properties are not inherent. ““[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).” MPEP § 2112.
Regarding claim 21, it would have been prima facie obvious to include an additional payload molecule in the method of making nano-silica yeast particles embraced by Caras. One would have understood in view of Ostroff that more than one payload may be incorporated into a nano-silica yeast particle. It would have been obvious to include the addition of a second payload in the method of making nano-silica yeast particles embraced by Caras. One of ordinary skill in the art would have been motivated to include an additional payload in order to imbue the yeast particle with multiple therapeutic functionalities. The artisan of ordinary skill would have had reasonable expectation of success because Ostroff teaches that yeast cell particles may include nanoparticles and one or more payloads [0026] and that multiplexed co-delivery of different payloads is possible [0072].
Regarding claim 22, it would have been prima facie obvious to add a trapping polymer to encapsulate the payload molecule in the method of making nano-silica yeast particles embraced by Caras. One would have understood in view of Ostroff that a trapping molecule may be added to facilitate encapsulation of the payload in the yeast particle. It would have been obvious to include such a trapping molecule in the method of making nano-silica yeast particles embraced by Caras. One of ordinary skill in the art at the time of filing would have been motivated to add a trapping polymer in order to facilitate a desired delivery property to the particle. The artisan of ordinary skill would have had reasonable expectation of success because Ostroff teaches that a trapping polymer may be added to facilitate encapsulation of the payload in the yeast particle [0117].
Response to Arguments
Applicant's arguments filed 1/26/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the rejection of claims 1, 3-5, 8, 11, 12, 14, 15, 17, 18, 23, 25, and 26 over Ostroff and claims 27, 29, and 30 over Ostroff and Mao under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On page 12, Applicant argues that Caras is limited to a particulate morphology consisting of a plurality of discrete, spherical MSNs and that even if one were to combine the teachings of Caras and Ostroff, the resulting composition remains a collection of disconnected silica spheres rather than the claimed unitary, continuous matrix. Applicant also argues that Applicant argues that Doekhie does not remedy the structural deficiencies of Ostroff and Caras and that there is no suggestion in the prior art of a composition where a continuous silica network fills the interior cavity of a yeast particle to form an integrated, cavity conforming cage. This is not found persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a unitary, continuous matrix) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The instant claims 19-22 are drawn to a nano-silica cage that encapsulates the payload and is confined to the inner cavity of the yeast particle and do not require a unitary, continuous matrix. Therefore, the argument is not persuasive and the rejection is maintained.
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.
Claims 1, 3-5, 8, 11, 12, 14, 15, 17-19, 21-23, 25-27, 29, and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8, 9, 11, 12, 15, 17, 19, 21-23, 26, 33, 36, 37, 39, and 40 of copending Application No. 18/611,933.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘933 application embrace a nano-silica yeast particle delivery system comprising a yeast particle with a hollow inner cavity and at least one first payload, wherein the at least one first payload is substantially encapsulated by a nano-silica cage and wherein the nano-silica cage and at least one first payload are both confined within the hollow inner cavity of the yeast particle. The yeast particle is selected from the group consisting of a yeast cell wall particle, a glucan particle, a yeast glucan particle, a yeast glucan-mannan particle, a glucan lipid particle, a whole glucan particle, a glucan mannan lipid particle, a glucan chitin particle and a mixture thereof. The payload is selected from a protein, a peptide, a peptide antigen, an enzyme, an antibody, a nanobody, an antigen binding fragment of an antibody, a single stranded nucleic acid, a double stranded nucleic acid, and any mixtures thereof. The nano-silica cage comprises a chemical selected from tetraethylorthosilicate, tetraethylorthogermanate, tetramethylorthosilicate, aminopropyl triethyoxysilicate, TEPI, BTEPDS, and BTEPTS. The yeast particle delivery system further comprises a nontoxic coating polymer with no pharmacologic activity on the outside of the nano-silica case or on the outside of the yeast particle. The coating polymer resists breakdown in the presence of gastric fluids in the oral cavity, esophagus, stomach or small intestine. The coating polymer is selected from methacrylic acid methylmethacrylate copolymer, methacrylic acid ethyl acrylate copolymer, cellulose acetate phthalate, cellulose acetate trimellate, hydroxy propyl methyl cellulose phthalate, hydroxyl propyl methyl cellulose acetate succinate, polyvinyl acetate, or methacrylic acid polymer. The payload is stable after a short-term or long-term exposure to high temperature wherein the payload is stable after exposure to a temperature of 25oC, 45oC, or 95oC for about 30 minutes, 2 hours, 5 hours, 15 days, 30 days, 45 days, 60 days, 75 days, or 90 days. The yeast particle may comprise a second payload. The yeast particle delivery system may include a pharmaceutically acceptable carrier or excipient. The claims of the ‘933 application also embrace a kit comprising the yeast particle delivery system and optional instructions for use.
The claims of the ‘933 application also embrace a method of preparing a nano-silica yeast particle delivery system comprising loading a yeast particle with at least one first payload, resuspending the yeast particle in partially pre-polymerized TEOS in half hydrodynamic volume, wherein the partially pre-polymerize TEOS is partially pre-polymerized at a pH of 2 to 4 and polymerized to form a nano-silica case within the hollow inner cavity of the yeast particle. The nano-silica cage has an encapsulation efficiency of at least 90% and the nano-silica cage and payload are both confined within the inner cavity of the yeast particle. The yeast particle may be loaded with a second payload and coated with an enteric polymer. The claims of the ‘933 also embrace a pharmaceutical composition comprising the yeast particle delivery system and a method of treating a disease in a subject comprising administering the pharmaceutical composition to a subject. The yeast particle may also be used in a vaccine for use in a method of preventing a disease condition in a subject.
The specification of the ‘933 application defines ensilicated to mean that a polymeric structure, like a “mesh net” covers or coats the payload such that payload inside the yeast particle is retained or entrapped within a polymeric structure formed by a silicate (pg. 15). The Examiner therefore considers the composition embraced by the claims of the ‘933 application to read on the “continuous, covalently bonded silica matrix in a mesh net form” limitation of the instant claims. The Examiner has relied upon the specification to delineate the scope of the invention embraced by the claims of the ‘933 application, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797.
The instant claims use the “comprising” language and therefore the additional steps and components in the copending claims are not excluded.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants’ request for the double patenting rejection of record to be held in abeyance is acknowledged. However, this request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02). Accordingly, the rejection will be maintained until a terminal disclaimer is filed or claims are amended to obviate the rejection.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614