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.
Previous Rejections
Applicant’s arguments, filed May 19, 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Restriction Requirement
Applicant’s election without traverse of Group I, claims 1-15, in the response dated 5/19/2026, is acknowledged.
Claim Status
Claims 4-5, 12, and 17-21 are cancelled.
Claims 21-27 are newly added.
Claims 1-3, 6-11, 13-16, and 21-27 are pending.
Claim 16 is withdrawn.
Claims 1-3, 6-11, 13-15, and 21-27 are examined on the merits in this prosecution.
Examiner’s Comment Regarding Objection to the Specification
The applicant argues in the Response dated 5/14/2026 that the disclosure in ¶ [0050] of the Specification “grammatically includes microparticle sizes that are within the range of 10 nm to 600 µm, as well as microparticle sizes outside of this range.” As such, applicant’s definition of “microparticle” is interpreted by the Examiner as including particles of any size.
In view of the applicant’s clarification, the objection is hereby withdrawn.
CLAIM REJECTIONS
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, 6-15, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Appel (US 2017/0319506 A1; of record), in view of Zhao (“Silk Fibroin-Based Nanoparticles for Drug Delivery,” Int. J. Mol. Sci. 2015, 16, 4880-4903), Chen (“Rheological Characterization of Nephila Spidroin Solution,” Biomacromolecules 2002, 3, 644-648), and Arndt (“Spidroin N-terminal domain forms amyloid like fibril based hydrogels and provides a protein immobilization platform,” Nature Communications (2022) 13: 4695, 1-14).
This is a new rejection necessitated by applicant’s amendment.
Appel teaches network materials which exhibit both shear thinning and self-healing properties. The networks contain particles and gel-forming compounds and are useful for a variety of biomedical uses, including drug delivery (Abstract). Appel teaches the networks are comprised of nanoparticles and polymers (pg 1, [0012]). The nanoparticles may be comprised of biodegradable polymers such as “alginate, collagen, chitosan, gelatin, hyaluronic acid, proteins such as, for example, but not limited to, fibrin, albumin, and zein, as well as non-biodegradable polymers such as polystyrenes, polyalkylene glycols, poly(meth) acrylates, poly(meth)acrylamides, polyalkylenes such as, for example, but not limited to, polyethylene, polyvinyls, poly(vinyl acetate), poly(ethylene terephthalate)” (pg 6, [0078]-[0079]). Appel also teaches the polymer may be a negatively charged polymer such as hyaluronic acid (HA) or carboxymethyl cellulose (CMC) (pg 2, [0026]). Appel also teaches water as a solvent (pg 3, [0036]).
For claim 2, Appel teaches the composition is a gel and it may be non-covalently cross-linked ([0036]).
For claim 3, Appel teaches the polymer may be a negatively charged polymers such as hyaluronic acid ([0026]).
For claims 6 and 23, Appel teaches the particles may be clays, such as silicates; minerals, including sulfides, oxides, halides, carbonates, sulfates, and phosphates; apatites; and/or one or more metals, such as gold, silver, copper, platinum, palladium, and ruthenium (pgs 6-7, [0086]).
For claim 7, silicates have a net negative charge.
For claim 8, Appel teaches size of the particles is from about 10 nm to about 1,000 nm (pg 6, [0085]), overlapping the claimed range. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
For claim 9, Appel teaches the polymers can be cationically charged (pg 7, [0099]), or anionically charged, as discussed above.
For claim 10, Appel teaches the composition can contain an injectable drug (pg 8, [0106]). Appel also teaches the composition is useful for delivering diagnostic agents (pg 9, [0112]).
For claim 11, Appel’s teaching of an injection indicates a sterile composition since one of ordinary skill would not inject a non-sterile material into a subject.
For claim 12, Appel teaches the composition is useful for DNA vaccines, and these can be stored, necessitating a container. See pg 9, [0111].
For claim 13, preparing and storing a stable composition in a sealed syringe is within the skill of an ordinary practitioner.
For claims 14-15, one of ordinary skill in the art would have been motivated to prepare a kit comprising the claimed composition because the preparation of a kit comprising a pharmaceutical composition, a syringe, and a needle is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art.
As discussed above, Appel teaches a range of particle sizes that overlap with the claimed range of “microparticles” in claim 8.
Appel does not teach the newly added limitation to claim 1 of “comprising a non-animal derived protein.”
Zhao, Chen, and Arndt teach the missing element of Appel.
Zhao teaches in the Abstract:
Silk fibroin (SF) is a protein-based biomacromolecule with excellent biocompatibility, biodegradability and low immunogenicity. The development of SF-based nanoparticles for drug delivery have received considerable attention due to high binding capacity for various drugs, controlled drug release properties and mild preparation conditions.
Zhao further teaches:
biodegradable polymer nanoparticles have been commonly used as drug delivery systems because of excellent biocompatibility, better encapsulation and controlled drug release properties. Various polymeric materials have been utilized as a drug delivery matrix, including the synthetic biodegradable polymers such as poly(lactic acid) (PLA), poly(ε-caprolactone) (PCL), and poly(glycolic acid) (PGA), and natural polymers such as polysaccharides, including cellulose, chitosan, hyaluronic acid, alginate, dextran, and starch, as well as proteins which contain collagen, gelatin, elastin, albumin, and silk fibroin
[see pg 4881, second full paragraph].
Chen teaches spider silk spinning solution (a.k.a. “spider dope”) shows shear thinning; the shear thinning properties are, in part, dependent on the concentration of the spider silk in the composition (Abstract).
Arndt teaches the hydrogels formed by the recombinant miniature spidroins provide straightforward immobilization of active proteins at high density (Abstract). Arndt teaches recombinant mini-spidroin that is composed of an N-terminal domain (NT), a short repeat region, a CT and a His6-tag for purification (His-NT2RepCT), is as soluble as native spider silk proteins in aqueous buffers and recapitulates important features of native spider silk dope (pg 2, left column). Arndt teaches “recombinant miniature spidroins, and importantly also the N-terminal domain (NT) on its own, rapidly form self-supporting and transparent hydrogels at 37 °C (Abstract). Arndt alto teaches gelation does not require cross-linking (Abstract).
For claim 22, Arndt teaches recombinant mini-spidroin that is composed of an NT, a short repeat region, a CT and a His6-tag for purification is produced by bioreactor fermentation of Escherichia coli expressing HisNT2RepCT (pg 2, left column).
The skilled artisan would have expected success in adding the non-animal derived protein recombinant spindroin to the drug delivery (Abstract) composition of Appel because Zhao teaches silk fibroin is a protein-based biomacromolecule with excellent biocompatibility, biodegradability and low immunogenicity that has a high binding capacity for various drugs, controlled drug release properties and mild preparation conditions and can be used as a substitute for natural polymers such as polysaccharides, hyaluronic acid and alginate; Chen teaches spider silk spinning solution (a.k.a. “spider dope”) shows shear thinning properties; and Arndt teaches recombinant spidroins, or spider silk, provide straightforward immobilization of active proteins at high density (Abstract). Arndt teaches recombinant mini-spidroin are soluble, transparent, and yield functionalized hydrogels with advantageous properties for a wide range of applications including controlled drug release (pg 8, right column, first full paragraph).
2) Claims 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Appel (cited above), in view of Zhao (cited above), Chen (cited above), Arndt (cited above), and Ruiz Esparza Herrera (WO 2021/127423 A1).
The teachings of Appel, Zhao, Chen, and Arndt are discussed above.
The combination of Appel, Zhao, Chen, and Arndt does not teach the limitations of “synthetic silicate layered clay microparticles” recited in claims 24, 25, and 27, or the limitation of “lithium magnesium sodium silicate microparticles” recited in claim 26.
Ruiz Esparza Herrera teaches the missing element of the combination of Appel, Zhao, Chen, and Arndt.
Ruiz Esparza Herrera teaches a composition comprising a plurality of silicate nanoparticles; a hydrophilic polymer; water; and one or more drugs or active agents (Abstract; pg 9:10-11). Ruiz Esparza Herrera teaches the silicate can comprise lithium magnesium silicate nanoparticles with a particle size from 1 nm to 500 nm (pg 26: 21-24). Ruiz Esparza Herrera teaches the silicate nanoparticle may be the commercial product Laponite® XLG (pg 28: 23-24). It is noted that the instant Specification discloses the following (see pg 10):
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It is noted that for claim 25, the combination of Zhao, Chen, and Arndt teach the microbially derived spidroin, Ruiz Esparza Herrera teaches the synthetic silicate layered clay microparticles, and Appel teaches both polymers and water.
Regarding the claimed opposite net charges of microparticles recited in claim 26, silicate layered particles of Ruiz Esparza Herrera have a negative net charge and Appel teaches net positive polymers such as chitosan, aminopolysaccharides, positively charged proteins, and cationically vinyl polymers (pgs 7-8, [0099]).
The skilled artisan would have expected success in substituting Reference a silicate nanoparticle such as the lithium magnesium silicate nanoparticle commercially known as Laponite® XLG as the claimed silicate nanoparticle because Appel teaches a silicate nanoparticle in the shear-thinning composition useful as drug carrier and Ruiz Esparza Herrera teaches the lithium magnesium silicate nanoparticle commercially known as Laponite® XLG as a species of silicate nano particle useful in a shear-thinning composition useful as a drug carrier.
Nonstatutory Double Patenting Rejections
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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
1) Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/252,740 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims in the reference application recite injectable shear-thinning composition comprising (a) one or more types of fibrous proteins, (b) one or more types of silicate microparticles, (c) one or more types of radiopaque additives, (d) one or more types of block copolymers, and (e) water. It is noted that the “fibrous protein” in reference claim 1 is a polymer comprising positive and negative charges, which can yield a physically crosslinked hydrogel composition, and the reference application Specification discloses fibrous proteins include non-animal derived proteins ([0034]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2) Claims 1-7 and 9-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 11-15 of copending Application No. 18/817,662 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims in the reference application recite injectable shear-thinning composition comprising (a) one or more types of fibrous proteins, (b) one or more types of silicate microparticles, (c) one or more types of radiopaque additives, (d) one or more types of block copolymers, and (e) water. It is noted that the “fibrous protein” in reference claim 1 is a polymer comprising positive and negative charges, which can yield a physically crosslinked hydrogel composition, and the reference application Specification discloses fibrous proteins include non-animal derived proteins ([00374]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner’s Reply to Attorney Arguments dated 5/19/2026
1. Rejection of claims 1-4 and 6-10 under 35 U.S.C. 102(a)(1) over Gaharwar,
and
2. Rejection of claims 11-15 under 35 U.S.C. 103 over Gaharwar,
These rejections have been withdrawn in view of applicant's amendment.
3. Rejection of claims 1-15 under 35 U.S.C. 103 over Appel.
The applicant argues this rejection is rendered moot in view of the claim amendment of 5/19/2026.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. The rejection over Appel, as set forth in the previous Non-Final Rejection, has been restruck in response to the newly added limitation of “comprising a non-animal-derived protein” to recite the new prior art of Zhao, Chen, and Arndt, which together teach the newly added limitation.
4. Provisional Double Patenting Rejections over 19/252,740 and 18/817,662
The applicant requests that these rejections be held in abeyance until the present application is otherwise in condition for allowance
The Examiner acknowledges the arguments presented, but does not consider them persuasive. A request to hold a rejection in abeyance is not a proper response to a rejection since it does not distinctly and specifically point out the supposed errors in the examiner' s action. See MPEP 714.02. Thus, the double patenting rejections of record have been maintained.
CONCLUSION
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 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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