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
Applicant's election with traverse of Group I, claims 1-4 and 6-14, in the reply filed on 07/06/2026 is acknowledged. The traversal is on the ground(s) that Group III are kit claims 22 and 24, while stated as apparatus in office action. This is not found persuasive because the device in the Group III kit claims reads into apparatus which is not included in Group I. The requirement is still deemed proper and is therefore made FINAL.
Claims 15-19, 21-22 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected groups, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/06/2026.
Status of Claims
Claim amendment filed on 07/06/2026 is acknowledged.
Claims 5, 20, 23 and 25 remain cancelled.
Claims 15-19, 21-22 and 24 are withdrawn due to being drawn to nonelected groups.
Claims 1, 11 and 14 are amended.
Claims 1-4 and 6-14 are pending and being examined on the merits herein.
Priority
The instant application 18627155, filed on 04/04/2024, is a CON of PCT/US2022077708, filed on 10/06/2022, which claims benefit of 63/253063, filed on 10/06/2021.
Information Disclosure Statement
The information disclosure statement (IDS), filed on 04/04/2024, 08/05/2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Claim Objection
Claim 2 is objected to because of the following informalities:
Acronym “tris” does not have definition of the full compound name. For the purpose of compact prosecution, it is interpreted as N,N,N-tris(3-dimethylaminopropyl)amine.
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 2, 6, 10, 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.
Claim 2 recites “or similar non-chelating organic buffer”. There is insufficient antecedent basis for this limitation in the claim, because only “non-chelating agent” has been previously mentioned in the claim or in claim 1, which claim 2 depends upon. It is unclear whether the non-chelating agent is meant to be the suspension buffer, and whether the non-chelating organic buffer is not the same as suspension buffer in claim 1. For the purpose of compact prosecution, the claim is interpreted as “or other non-chelating organic agents”.
Claim 6 recites the limitation "the one or more antigens” at the end of the claim. There is insufficient antecedent basis for this limitation in the claim, because claim 1, which claim 6 depends upon, does not have “one or more antigens”. For the purpose of compact prosecution, the claim is interpreted as “the antigen”.
Claim 10 recites “does not contain at least one of sulfate and citrate”. It is unclear whether it is meant to be one of sulfate or citrate can be contained, or it is meant to be both sulfate and citrate are not contained, because “does not contain” means to be exclusive, while “at least one of” means one can be included. The conflict meaning renders the claim indefinite. The claim is interpreted as “does not contain sulfate and citrate”.
Claim 14 recites “were essentially dry immediately prior to”. It is unclear what “dry immediately” is supposed to mean here: whether it is meant to be the microparticles were not dry in general, but got to dry immediately prior to combining with the aqueous formulation? However, combining with the aqueous formulation is apparently making the microparticles wet in the aqueous formulation instead of being “essentially dry”. The limitation is thus indefinite due to the unclear status of when exactly the microparticles have to be dry. The claim is interpreted as “were essentially dry prior to”.
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 6 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 6 recites “the one or more antigens”. According to claim 1, which claim 6 depends upon, only “at least one of an antigen and a therapeutic agent” is mentioned, therefore, “the one or more antigens” rather broadens the “an antigen” scope in claim 1 than further limiting the subject matter.
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
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 1-4 and 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over Klaus et al. (CN113164897, 07/23/2021, Translation relied upon below; attached, PTO-892) in view of Sabtanarua (WO2020237160, 11/26/2020, IDS of 04/04/2020; attached, PTO-892).
Klaus throughout the refence teaches a method for producing microparticles as carriers of active substances wherein the active materials, e.g., enzymes, catalysts and bacteria, a bioactive polymer such as protein, lipoprotein, proteoglycan, or nucleic acid (e.g., [0010-0011]) are embedded in a matrix and/or the microparticle (e.g., Abstract; [0001-0002]).
For Claim 1, Klaus teaches the microparticles are impregnated with the corresponding liquid (1a), (1b), (1c) or (1d) (e.g., [0058]; [0064]; [0066]; [0082]), comprising at least one active substance, (e.g., [0323]), or a mixture of multiple active substances (e.g., [0325-0326]), e.g., preferred active therapeutic ingredients (APIs) such as proteins, nucleic acids, and many other drugs [0377-0378], wherein the liquid can be aqueous solution or emulsion of water-soluble polymer mixed with the active substance (e.g., [0508]), or aqueous solution of dispersant can be added to the W/O emulsion to obtain a W/O/W emulsion (e.g., [0296-0297]), resulting in aqueous composition comprising microparticles containing therapeutic agents.
Klaus teaches that the particles are sealed by applying a material used to seal the pores of the filled particles to the surface of the particles that have been filled with the active substance (e.g., [0637]), for the purpose, the process preferably involves applying a solid coating to the surface of the particles that have been filled with an active substance (e.g., Claims 16-17; [0638]), and the solid coating to the surface of particles can be performed in a manner similar to known methods, such as chemical vapor deposition or related atomic layer deposition (ALD) techniques [0691]), typical coatings deposited by this method generally include Al2O3, TiO2, ZrO2, Ta2O3, as metal oxide coating on the surface of particles [0693].
Klaus teaches the aqueous solution of the dispersant for the microparticles can include cellulose derivatives, polyethylene glycol, polyvinyl alcohol, e.g., 4 wt% aqueous solution having a viscosity of 20-30 mPa.s (e.g., [0311]; [0306]), which corresponds to non-chelating agent; and indicates that suitable liquid for use are water and organic solvents including methanol, ethanol, isopropanol, etc., especially those that cannot dissolve wall materials (e.g., [0652]; [0634]; [0445]) (corresponding to the suspension solution does not contain an agent capable of dissolving or reducing the integrity of the wall materials in instant claim).
For Claims 2 and 3, Klaus teaches that polymerization catalysts can be used including N,N,N-tris(3-dimethylaminopropyl)amine (same as tris; [0395]), N-(2-hydroxypropyl) imidazole, N-(2-hydroxyethyl)imidazole, N-(2-aminopropyl)imidazole (e.g., [0397]), corresponding to non-chelating agent tris and imidazole.
For Claim 6, Klaus teaches the microparticles are filled with the active substance (e.g., Claims 1 and 3) including APIs (e.g., [0377-0378]), and a solid coating is formed on the surface of the particles (e.g.,Claim 16) via method like chemical vapor deposition or related atomic layer deposition (ALD) techniques [0691]) using typical metal oxide coating [0693]. Since prior art teaches the same ALD coating method using metal oxide, as an outcome, the at least one covalently attached molecule-thick layer of the metal oxide completely covering the active therapeutic agent would necessarily present or would be capable of being achieved by prior art.
For Claim 7, Klaus teaches the compositions can contain surfactants (e.g., [0725]), antimicrobial drugs (e.g., [0378]), preservatives (e.g., [0389]).
For Claim 8, Klaus teaches that preservatives include the conventional ones known to those skilled in the art, preferably phydroxybenzoic acid esters, imidazolidinyl urea, formaldehyde, sorbic acid, benzoic acid, salicylic acid, etc. (e.g., [0389]).
For Claim 9, Klaus does not require chelating agent in the composition.
For Claim 10, Klaus does not teach the composition comprising therapeutic agents sulfate or citrate.
For Claim 13, Klaus teaches pH adjusters such as magnesium carbonate or zinc carbonate can be used [0012], and organic polymers that are soluble in aqueous solvents [0457] are proper for the composition, such as those soluble in water at neutral or alkaline pH levels, but insoluble in water at pH levels below [0459], or vice versa [0460], and polymers soluble in both acidic and alkaline pH values, release can be carried out in a controlled manner in the stomach or intestine (e.g., [0709], suggesting that pH of the polymers or the composition pH can be adjusted and proper values are based on desirable intended uses.
For Claim 14, Klaus teaches the microparticles are in powder form in the operation of treating the microparticles with liquid (1a), (1b), (1c) or (1d) (e.g., Claim 25), the particles formed by removing water-immiscible solvents and preferably dried (e.g., [0320]) via suitable methods including filtration, decantation, drying, vacuum drying, or spray drying (e.g., [0446]), indicating that the prior to combining with aqueous formulation, the microparticles comprising therapeutic agent can be essentially dry.
Klaus does not teach the aqueous composition comprising a suspension buffer as recited in instant claim 1, the one or more non-chelating agent concentration is about 0.1 mM to about 100 mM as in instant claim 4, or the composition comprises at least one antigen as the specified agents in instant claim 11, or comprising the non-chelating agent is isotonic as instant claim 12, composition pH is about pH 6.0 to about 8.0 as recited in instant claim 13.
Santamaria throughout the reference teaches compositions comprising antigens associated with histocompatibility complexes (MHCs) and coupled to a nanoparticle core to induce regulatory T cells and regulatory B cells (e.g., Abstract).
Santamaria teaches the nanoparticle complexes are administered suspended in a sterile solution, comprising e.g., 0.9% NaCl (isotonic non-chelating agent, corresponding to instant claim 12), buffers (for example, histidine, hydroxymethylaminomethane Tris), surfactants, glycine, etc. (e.g., [00133]) (corresponding to suspension buffer in instant claim 1, non-chelating agent species in instant claims 2-3, one or more agents in instant claim 7). Santamaria teaches that NPs can be dissolved in 20 mM MES buffer, pH 5.5; N-hydroxysulfosuccinimide sodium salt (sulpha-NHS, 10 mM) and EDC (1mM) is added to the NP solution; Later the NP solution is added drop-wise to the solution containing pMHC monomers dissolved in 20 mM borate buffer (pH 8.2) [0099], corresponding to the suspension buffer in instant claim 1, and the non-chelating buffers with overlapping range of about 0.1 mM to about 100 mM concentration range in instant claim 4.
Santamaria teaches that the antigen-MHCs compositions comprising ubiquitous autoantigens associated with MHC and coupled to a nanoparticle core (e.g., Claim 1) wherein the nanoparticle core is metal or metal oxide (e.g., Claim 2), e.g., iron oxide (Claim 5), the ubiquitous autoantigens are various polynucleotides (e.g., [0031]), polypeptides (e.g., Claims 16-17 and 20-34; [0038-0044]), corresponding to instant claim 11.
Santamaria teaches that the uaMHC-NP complexes can be buffered at a certain pH, generally less than 7.0, e.g., between 4.5 and 6.5 [00133]. Santamaria also teaches the unconjugated pMHCs in the different MHC-NP conjugating reactions can be removed by extensive dialysis against PBS, pH 7.4 (phosphate buffered saline, known as isotonic buffer, corresponding to instant claim 12, overlapping with about pH 6.0 to about 8.0 in instant claim 13.
It would have been prima facie obvious for a person with ordinary skills in the art prior to filing date to incorporate the teaching from Santamaria of suspension buffers, antigens, isotonic non-chelating agents into the microparticle composition of Klaus to arrive at current invention. Because Klaus already indicates that polypeptides, proteins are suitable therapeutic agents for the microparticles that are coated with metal oxide, while Santamaria implements polypeptide antigens for the nanoparticle complex coupled with metal oxide, it naturally flows with the logic for artisans in the field to use antigens for the microparticles. Similarly, Klaus teaches using aqueous solutions for suspending the microparticles, while Santamaria teaches suspension buffers including isotonic non-chelating agents that can stabilize the antigen nanoparticle complex, artisans in the field would have motivation to select these specific agents for reasonable expectation of success, as demonstrated by Santamaria that the conjugated NPs are stable for at least 6 months in PBS at about 4 C without any detectable degradation or aggregation (e.g., [00118]). This renders obviousness as “use of known technique to improve similar
devices (methods, or products) in the same way” or as “applying a known technique to a known device
(method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and
(I)(D). Furthermore, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). MPEP 2144.01 points out "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the non-chelating agent concentration and pH ranges overlap with those taught by prior art. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONGXIU ZHANG SPIERING whose telephone number is (703)756-4796. The examiner can normally be reached 7:30am-5:00pm (Except for Fridays).
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/DX.Z./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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