DETAILED ACTION
Status of Application
Claims 1-20 are pending
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election with traverse of Group I, claims 1-14, drawn to a composition of matter comprising: water; a water- soluble comb polyelectrolyte; a positively charged water-soluble macromolecule; and a negatively charged water-soluble macromolecule; wherein the water-soluble comb poly electrolyte, the positively charged water-soluble macromolecule and the negatively charged water-soluble macromolecule form complex coacervate droplets, and a method of making a complex coacervate, and Applicant’s species election with traverse of polypeptides, as submitted in communication filed on 07/09/2026 is acknowledged.
Applicant’s traverse is on the grounds that the subject matter of each of the claim Groups are linked by a common inventive concept. Applicant’s arguments have been fully considered but not deemed persuasive to withdraw the restriction requirement. As discussed in the 06/26/2026 restriction, complex coacervates have been taught previously. Therefore, contrary to Applicant’s assertions, the groups of inventions do not relate to a single inventive concept. The requirement is deemed proper and therefore is made FINAL.
Claims 15-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/09/2026.
Claims 1-14 are at issue and will be examined to the extent they encompass the elected invention.
Priority
Acknowledgment is made of applicant’s claim for domestic priority under 35
U.S.C. 119 (e) to provisional Application No. 63/187031 filed on 05/11/2021.
This is the US national application which entered the national stage from
Application No. PCT/US22/28766 filed on 05/11/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/09/2023 and 06/12/2025 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings submitted on 11/09/2023 have been reviewed and are accepted by
the examiner for examination purposes.
Claim Objections
Claim 3 is objected to due to the recitation of “…and/or (e) the composition further comprises…”. It should be amended to remove the “(e)”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
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 3-4, and 13 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 3-4, and 13 are indefinite in the recitations of “concentration ranges from 0.05 to 1” and “concentration ranges from 0 to 0.3”, for the following reason: No units of concentration are provided. Therefore, it is unclear what charge concentration is required in this case. Correction is required.
Claim 3 (claim 4 dependent thereon) is indefinite in the recitation of “(e)” due to the following reason: Elements (a)-(d) are missing. Therefore, it is unclear what the limitations of (a)-(d) are in this case. Correction is required.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As stated in MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow.
Claims 1-14 are directed in part to a composition of matter comprising water; any water-soluble comb polyelectrolyte; any positively charged water-soluble macromolecule; and any negatively charged water-soluble macromolecule. See claim rejections under 35 usc 112(b) for claim interpretation.
The claims encompass a large genus of water-soluble comb polyelectrolytes, positively charged water-soluble macromolecules, and negatively charged water-soluble macromolecules, which are structurally unrelated. A sufficient written description of a genus of water-soluble comb polyelectrolytes, positively charged water-soluble macromolecules, and negatively charged water-soluble macromolecules may be achieved by a recitation of a representative number of water-soluble comb polyelectrolytes, positively charged water-soluble macromolecules, and negatively charged water-soluble macromolecules defined by recitation of structural features common to members of the genera, which features constitute a substantial portion of the genera. However, in the instant case, there is no recited structural feature which is representative of all the members of the genera of water-soluble comb polyelectrolytes, positively charged water-soluble macromolecules, and negatively charged water-soluble macromolecules recited in the claims, and there is no information as to which are the structural elements of any water-soluble comb polyelectrolyte, positively charged water-soluble macromolecules, and negatively charged water-soluble macromolecule that are essential for the formation of the recited coacervate. Furthermore, while one could argue that the species disclosed is representative of the structure of all the members of the genera of water-soluble comb polyelectrolytes, positively charged water-soluble macromolecules, and negatively charged water-soluble macromolecules required, it is noted that the art teaches examples of how coacervation depends on a careful balance the electrostatic components. For example, Moulik et al. (Colloids and Interfaces 6.3 (2022): 45) teach that the concentration, solubility, molecular weight, charge density, and hydrophobicity of each component that makes coacervates as well as their solution conditions (temperature, pH, salt, and solvent) determine the formation of coacervates (Page 4 [3]). Therefore, since the charged components’ concentration, solubility, molecular weight, charge density, and hydrophobicity may result in changes affecting the formation of coacervates, and no additional information correlating structure with the desired functional characteristics has been provided, one of ordinary skill in the art would not recognize from the disclosure that Applicant was in possession of the claimed invention.
Claim Rejections - 35 USC § 103 (AIA )
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.
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.
Claims 1-2, 8-10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Russell et al. (US 9867899 B2 Published 01/16/2018), in view of Hawkett (US 8765183 B2 Published 07/01/2014).
Russell teaches the synthesis of reinforced adhesive complex coacervates and their use thereof wherein the reinforced adhesive complex coacervates are composed of (a) at least one polycation, (b) at least one polyanion, (c) a reinforcing competent (abstract). Russell teaches the formation of complex coacervates by adjusting the pH of a solution of polycations and polyanions wherein the oppositely charged polycations and polyanions associate into colloidal polyelectrolyte complexes (PECs) (FIG. 1) (Column 3, lines 1-10). Russell teaches that the polycation is generally composed of a polymer backbone with a plurality of cationic groups at a particular pH wherein the cationic groups can be pendant to the polymer backbone and/or incorporated within the polymer backbone; wherein the polycation is any biocompatible polymer possessing cationic groups or groups that can be readily converted to cationic groups (Column 5, lines 65- Column 6, lines 9). Russell teaches coacervate formation comprising water (Column 22, lines 60-61) (Column 30 [line 45-67]). Russell that teaches that the polycation can be a biodegradable polyamine; wherein the biodegradable polyamine includes a polysaccharide, a protein, or a synthetic polyamine (Column 6, lines 64-67). Russell that teaches that Polysaccharides like chitosan can be used as a polycation (Column 7, line 1). Russell teaches that the polyanion can be a synthetic polymer or naturally-occurring (Column 10, 5-6). Russell teaches that the catonic groups can be pendant to the polymer backbone and/or incorporated in the polymer backbone (Column 5, line 65-Column 6-, line 1). Russell teaches that examples of naturally-occurring polyanions include glycosaminoglycans such as condroitin sulfate, heparin, heparin sulfate, dermatan sulfate, and hyaluronic acid (Column 6-10). Russell teaches that the anionic groups can be pendant to the polymer backbone and/or incorporated in the polymer backbone (Column 10, lines 13-15). Russell teaches that the complex coacervates can encapsulate one or more bioactive agents; wherein the bioactive agents can be any drug including, but not limited to, antibiotics, pain relievers, immune modulators, growth factors, enzyme inhibitors, hormones, mediators, messenger molecules, cell signaling molecules, receptor agonists, or receptor antagonists (Column 27, lines 53-59). Russell teaches that the bioactive agent can be a nucleic acid; wherein the nucleic acid can be an oligonucleotide, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or peptide nucleic acid (PNA) (Column 27, lines 60-63). Russell teaches that the bioactive agent can be bone morphogenetic proteins (BMPs) (Column 28, lines 8-10).
Russell does not teach a composition comprising a water-soluble comb polyelectrolyte.
Hawkett teaches the use of comb polymer structures as a stabiliser (Column 18, lines 14-15).
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 coacervate composition of Russell to incorporate a comb polyelectrolyte. A person of ordinary skill in the art is motivated to incorporate a comb polyelectrolyte because Russell teaches the formation of polyelectrolyte complexes and Hawkett teaches that comb polymers function as stabilizers. Therefore, the incorporation of a comb polyelectrolyte would be expected to improve the stability of the coacervate. One of ordinary skill in the art has a reasonable expectation of success at arriving to incorporating a comb polyelectrolyte because all that is required is using the known benefits of comb polymers to improve the composition of Russell.
Claims 3-4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Russell et al. (US 9867899 B2 Published 01/16/2018 herby “Russel), in view of Hawkett (US 8765183 B2 Published 07/01/2014 hereby “Hawkett”), as applied to claims 1-2, and 8, in further view of Scheuing et al. (US 10208275 B2 Published 02/10/2019; hereby “Scheuing”).
The combined teachings of Russell and Hawkett are discussed above.
Russell and Hawkett do not teach the claimed charge ratios and macromolecule concentrations.
Scheuing teaches aqueous compositions of associative polyelectrolyte complexes (PECs), optionally containing surfactants, biocidal agents and/or oxidants (abstract).
Scheuing teaches a composition comprising: (i) water; (ii) an anionic surfactant; (iii) an oxidant; (iv) at least one water-soluble associative polyelectrolyte complex comprising a water soluble cationic first polyelectrolyte; and a water soluble second polyelectrolyte bearing groups of opposite charge to said first polyelectrolyte; wherein the resulting water-soluble associative polyelectrolyte complex is non-precipitating in the treatment composition, wherein R, the molar ratio of charged groups present on said first polyelectrolyte to oppositely charged groups present on said second polyelectrolyte is from about 0.10 to 20; wherein said cationic first polyelectrolyte and said second polyelectrolyte each comprise at least one of homopolymers, random copolymers, alternating copolymers, or mixtures thereof; wherein the at least one associative polyelectrolyte complex has an average aggregate size in solution of less than about 500 nanometers; and (viii) wherein film formation of the at least one water-soluble associative polyelectrolyte complex during use to treat a surface is self-limiting so as to not grow to macroscopic dimensions which would otherwise become visible to the eye, but instead maintaining a film thickness of less than about 500 nm (Claim 1). Scheuing teaches that the method of forming at least one associative polyelectrolyte complex is done at a concentration of less than or equal to about 100 millimolar with respect to the total concentration of charged associating groups present on the polyelectrolytes making up a plurality of associative polyelectrolyte complexes. Scheuing teaches that the cationic polymer levels in the compositions of the PECs are typically from about 0.001 wt % to about 5.0 wt %, or from about 0.01 wt % to about 2.5 wt %, or from about 0.01 wt % to about 1.0 wt %, or from about 0.1 wt % to about 0.50 wt % (Column 9, lines 40-44). Scheuing teaches that the anionic polymer levels in the compositions of the PECs are typically from about 0.001 wt % to about 5.0 wt %, or from about 0.01 wt % to about 2.5 wt %, or from about 0.01 wt % to about 1.0 wt %, or from about 0.1 wt % to about 0.50 wt % (Column 10, lines 14-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the claimed charge ratios and macromolecule concentrations to form the complex coacervate taught in the combined teachings of Russell and Hawkett. A person of ordinary skill in the art is motivated to utilize the claimed charge ratios and macromolecule concentrations because the claimed ratios and concentration produce stable polyelectrolyte complexes in aqueous solutions as taught by Scheuing. Additionally, one of ordinary skill could optimize the charge ratios and macromolecule concentrations to arrive at the recited charge ratios and macromolecule concentrations through routine experimentation, as the charge ratios and macromolecule concentrations needed would depend on the charged components used. One of ordinary skill in the art has a reasonable expectation of success at arriving to the claimed ratios and concentration to produce stable polyelectrolyte complexes because all that is required is selecting the known ratios and concentrations of Scheuing to form complex coacervates.
Claims 5-7 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Russell et al. (US 9867899 B2 Published 01/16/2018), in view of Hawkett (US 8765183 B2 Published 07/01/2014), and Scheuing company (US 10208275 B2 Published 02/10/2019) as applied to claims 1-2 and 8, and 13 in further view of Zhang et al. (Soft Matter (2015) 11 (37): 7392–7401; hereby “Zhang”), and Zhang et al. (Pharmaceutical research 30.5 (2013): 1228-1239; hereby “Zhang2”).
The combined teachings of Russell, Hawkett, and Scheuing are discussed above.
Russell and Hawkett do not teach the claimed coacervate mean diameter, charge ratios and macromolecule concentrations.
Scheuing does not teach the claimed the charge ratios and macromolecule concentrations.
Russell, Hawkett, and Scheuing do no teach a complex coacervate that exhibits turbidity at concentrations of 100, 250 or 500 mM NaCl; wherein the complex coacervate remains stable for 12, 24 or 48 hours following a >120-fold dilution from a concentrated single-phase solution of the complex coacervate; and/or the complex coacervate spontaneously encapsulates polypeptides disposed in the composition.
Russell, Hawkett, and Scheuing do no teach a complex coacervate wherein the positively charged water-soluble linear polyelectrolyte is present in amounts from 0.1 mM-3000 mM; the negatively charged water-soluble linear polyelectrolyte is present in amounts from 0.1 mM-3000 mM; the water-soluble comb polyelectrolyte is present in amounts of at least 0.1 mM; and/or sodium chloride is present in amounts from 1 to 1000 mM.
Scheuing teaches that the associative PECs of are assembled in such a way that they have an average aggregate size in solution most preferably less than 10 mM (Column 7, lines 12-28).
Zhang teaches Polyelectrolyte complexes (PECs) formed by mixing polycation, PDAC, and polyanion, PSS, solutions together (abstract). Zhang teaches time-lapsed digital images ranging from 0 minutes to 25 hours of stable PECs formed by mixing PDAC and PSS exhibiting turbidity (Fig. 1a). Zhang teaches stable, unstable, and dissolving PECs (20mol% PDAC and 0.5M NaCl, 50 mol% PDAC and 0.5M NaCl, and 50 mol% PDAC and 3 M NaCl, respectively) exhibiting turbidity over a course of time (Fig. 3). Zhang teaches a diagram of the colloidally stable/unstable and colloidally unstable/solution boundaries for PDAC–PSS complexes; wherein said complexes are stable at 1.5 M NaCl to near 0 M NaCl (Fig. 8).
Zhang2 teaches siRNA encapsulated by nanoparticles (Page 1231 [1-3]). Zhang2 teaches preparation of said Nanoparticles involving mixing polycation, Chitosan, polyanion, TPP, and siRNA (Page 1230 [3]). Zhang2 teaches that chitosan/siRNA/TPP particle size does not significantly change with a dilution of 250 (Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Zhang and Zhang2 into the combined teachings of Russell, Hawkett, and Scheuing. A person of ordinary skill in the art is motivated to form a complex coacervate with the claimed diameter, salt stability, dilution method, polyelectrolyte concentrations, and stability over time because Zhang teaches that polyelectrolytes exhibit stability and turbidity at various NaCl concentrations and over a span of 25 hours and Zhang2 teaches that such complexes can maintain particle integrity following dilution. Additionally, one of ordinary skill could optimize the concentrations and parameters to arrive at the recited concentrations and parameters through routine experimentation, as the parameters and concentrations needed would depend on the charged components used. One of ordinary skill in the art has a reasonable expectation of success at arriving to utilizing the recited parameters and concentrations because all that is required is optimizing known coacervate parameters to achieve predictable coacervate stability.
Conclusion
No claim is in condition for allowance.
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/S.L.S./Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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