DETAILED ACTION
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/19/2025 has been entered.
Previous Rejections
Applicant’s arguments, filed December 19, 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 44 is objected to because of the following informality:
Claim 44 depends from a cancelled claim. In the interest of compact prosecution, the Examiner is interpreting claim 44 to depend from claim 17, however, appropriate correction is required.
Claim Rejections - 35 USC § 112, Second Paragraph
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 17-26 and 35-44 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 17, lines 10-11 recites “a matrix-type or mold-type particle”. The addition of the word "type" to an otherwise definite expression extends the scope of the expression so as to render it indefinite. See MPEP 2173.05(b).III.E. In the instant case, the addition of the word “type” to the definite terms, “matrix or mold”, renders the phrase “a matrix-type or mold-type particle” indefinite.
Claim Rejections - 35 USC § 112- Failure to Further Limit
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.
Claims 22, 24, 26, 35-37 and 43 are 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 22 recites, “wherein the protein-based shell comprises a protein selected from whey protein, soya protein, pea protein, fava bean protein, and potato protein or any combination thereof”. Claim 22 depends from claim 17 which recites the same list of proteins, therefore, claim 22 fails to further limit claim 17.
Claim 26 recites, “the hydrophilic or amphiphilic biological compound is selected from”. Claim 26 depends from claim 25 which recites, “the hydrophilic or amphiphilic biological compound is a hydrophilic compound”. Thus, claim 26 broadens the scope of claim 25 by stating that the biological compound may be amphiphilic.
Claim 35 recites, “said polysaccharide coating is a cationic polysaccharide”. Claim 35 depends from claim 19 which already defines the polysaccharide coating to have a cationic polysaccharide, therefore, claim 35 fails to further limit claim 19.
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
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 17, 20-22, 25-26 and 38-42 are rejected under 35 U.S.C. 103 as being as being obvious over Hauser (US 2023/0151370 A1) in view of Koyakutty et al. (US 2017/0333365 A1).
Regarding claim 17, Hauser discloses polynucleotide nanoparticles for nucleotide delivery [0003] [0023] with a polynucleotide nanoparticle core comprising RNA (a hydrophilic biological compound) and a shell comprising one or more surface moieties (Claim 9), such as peptides and proteins (Claim 2). The particle contains RNA both in the central core and distributed within the shell (Fig 1-2) [0109]-[0110].
Hauser does not disclose that the protein is whey protein or soya protein.
Koyakutty teaches a core/shell particle for delivering therapeutic agents, such as RNA [abstract] [0009]-[0010]. The core is loaded with the therapeutic agent (e.g., RNA) and the particle comprises one or more proteins, such as whey or soy protein, forming a shell encapsulating the core to form the particle [0009]-[0010]. Koyakutty teaches that the proteins are ideal for delivering therapeutics because of their biocompatibility and biodegradability coupled with low toxicity. Additionally, the degradation products will be amino acids, which are well tolerated by the human body [0004].
Since Hauser generally discloses particles for nucleotide delivery, it would have been prima facie obvious to one of ordinary skill in the art to include whey or soy protein, within the teachings of Hauser, because Koyakutty teaches a whey/soy protein shell encapsulating a nucleotide core. An ordinarily skilled artisan would be motivated to use a protein, such as whey/soy protein because Koyakutty teaches that the proteins are ideal for delivering therapeutics because of their biocompatibility and biodegradability coupled with low toxicity. Additionally, Koyakutty teaches the degradation products will be amino acids, which are well tolerated by the human body [0004].
Furthermore, generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, since Hauser generally taught a shell comprising proteins, it is prima facie obvious to select whey/soy protein for incorporation into the shell based on their recognized suitability for the intended use as proteins for a shell to deliver therapeutic agents, such as RNA, as taught by Koyakutty.
Regarding the claim 17 limitation of the particle being in the form of a matrix structure, thus obtaining a matrix or mold particle, the instant specification defines a matrix/mold particle as a particle where the active principle is distributed not only in the core, but also in the protein-based shell (pg. 8, lines 26-29). Hauser meets this limitation because Hauser discloses the particle contains RNA both in the central core and distributed within the shell (Fig 1-2) [0109]-[0110], where the shell comprising one or more surface moieties (Claim 9), such as peptides and proteins (Claim 2).
Further regarding claim 17, the limitation of “obtainable by the method according to claim 1” is interpreted as a product-by-process limitation. Even though the product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, then the claim is unpatentable even though the prior product was made by a different process. In the instant case, the combined teachings of Hauser and Koyakutty read on the claimed particle. As such, the patentability of the instant claim does not depend on its method of production, and the Applicant' s limitation regarding the method of preparation is not patentable, in view of Hauser and Koyakutty.
Claims 20-21 and 38-42 are rendered prima facie obvious because Hauser discloses the particles have a diameter from 20-200 nm [0036] [Fig 2]. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
Claim 22 is rendered prima facie obvious because it would have been obvious to include whey/soy protein as taught by Koyakutty, within the teachings of Hauser, as previously discussed.
Claims 25-26 are rendered prima facie obvious because Hauser discloses the hydrophilic biological compound, RNA (Claim 9) (Fig 1-2) [0109]-[0110].
Claims 18-19 and 35-37 are rejected under 35 U.S.C. 103 as being as being obvious over Hauser (US 2023/0151370 A1) in view of Koyakutty et al. (US 2017/0333365 A1) and further in view of Frank et al. (Reactive and Functional Polymers, 2020, 147:104459).
The 35 U.S.C. 103 rejection over Hauser in view of Koyakutty was previously discussed.
Hauser does not disclose the particle has a polysaccharide coating, as recited in claim 18, where the polysaccharide coating is a cationic polysaccharide, as recited in claims 19 and 35, where the polysaccharide is chitosan, as recited in claims 36-37.
Frank discloses nanoparticles coated with chitosan for the delivery of therapeutics (abstract; pg. 7, right column; pg. 9, right column). Frank teaches that the chitosan coating confers many advantages including improved physicochemical stability; ii) controlled drug release iii) promoting mucoadhesiveness and tissue penetration iv) modulating cell interactions (cellular uptake and toxicity), v) enhancing antimicrobial effects, and vi) improving bioavailability and drug efficacy (pg. 1).
Since Hauser generally discloses particles for the delivery of therapeutic agents, it would have been prima facie obvious to one of ordinary skill in the art to include a chitosan coating, within the teachings of Hauser, because Frank teaches that a chitosan coating confers many advantages including improved physicochemical stability; ii) controlled drug release iii) promoting mucoadhesiveness and tissue penetration iv) modulating cell interactions (cellular uptake and toxicity), v) enhancing antimicrobial effects, and vi) improving bioavailability and drug efficacy (pg. 1).
Response to Arguments
Applicant's arguments with respect to claim(s) 17-22, 25-26 and 35-42 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.
Analysis of Unexpected Results
In the final rejection dated 09/25/2025 at pg. 7-8, the Examiner reviewed Examples 1-10 of the as-filed specification to analyze the unexpected results alleged by the applicant. It was determined that the subject matter of claims 24 and 34 are commensurate in scope with the showing of unexpected results and are free of prior art. Claim 34 has since been cancelled. Newly added claims 43 and 44, which recites hydrolysate whey protein are commensurate in scope with the showing and are free of prior art for the same reasons discussed in the final rejection.
The applicant has submitted additional supporting experimental data which is argued to “support all the proteins claimed in amended claim 17”. Applicant argues that claim 17, as amended, is now commensurate in scope with the showing.
The Examiner has fully reviewed and considered the declaration submitted 12/19/2025 showing the transfection efficiency of select proteins in hydrolysate or isolate form vs. a non-encapsulated particle (negative control).
The evidence submitted by the applicant shows that the tested protein hydrolysates generally showed higher activity while protein isolates showed lower transfection capability (pg. 6, Table 1). The transfection efficiency of the tested proteins being higher in hydrolysate form is unexpected over the prior art and the subject matter of claim 23 is now deemed commensurate in scope with the showing and is free of prior art.
However, the Examiner disagrees that claim 17, as amended, is now “commensurate in scope” with the showing. Claim 17 does not recite that the claimed proteins are in their hydrolysate form and many of the proteins in their isolate form (which is within the scope claimed) do not have unexpected, beneficial properties. For example, pea protein and potato protein in their isolate form do not have better transfection efficiency than the negative control (Table 1). Therefore, it is unclear that a comparative composition containing the specific components (i.e., tested proteins in hydrolysate form) would be reasonably representative of compositions containing other forms of the proteins (e.g., isolate form) falling within the broader scope currently claimed.
Potentially Allowable Subject Matter
Claims 23-24 and 43-44 are now considered free of prior art since unexpected results have been demonstrated by the applicant.
Claim 23-24 and 43-44 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b)/35 U.S.C. 112(d) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Assuming arguendo that the 112 rejections will be overcome, applicant should note that it will then be necessary to amend claims 23-24 and 43-44 to include all the limitations of the intervening claims. This includes incorporating the subject matter of claim 1 into claim 17 or placing claim 1 in condition for rejoinder.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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/ASHLEE E WERTZ/Examiner , Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612