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 .
Response to Amendment
Applicant’s response of 02/13/2026 has been received and entered into the application file. Claims 1-2, 6, 12-18, 21, 23-25, 28-29, 31-33, 35-36, 38-40, 42-44, 47-48 and 68-72 are pending in this application. New claims 68-72 are added.
Applicant’s amendments to the Specification and claims have overcome 102 and 112(b) rejection previously set forth in the Non-Final Office Action mailed 10/28/2025.
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.
Elected Species
In the reply to restriction and election of species requirements of 08/26/2025, the applicants have elected peptide as the species of active pharmaceutical ingredient. Any and all semi-solid injectable formulations containing any peptide will read on claim 1.
Claims 1-2, 6, 12-18, 21, 23-25, 28-29, 31-33, 35-36, 38-40, 42-44, 47-48 and 68-72 are rejected under 35 U.S.C. 103 as being unpatentable over Donovan (US 2017/0216529 A1) Shen et al. (US 2005/0042194 A1) and Chen et al. (WO 2020/106948 A1).
Donovan discloses a syringe body defining a reservoir having an internal first transverse dimension, a paste disposed within the reservoir, the paste having a solids concentration of greater than 50 mg/mL, the needle configured to be in fluid communication with the reservoir to allow intracutaneous delivery of the paste, and a plunger and/or piston disposed within the reservoir and configured to be moved to dispense paste from the reservoir through the lumen (Abstract). In some embodiments of the present pre-loaded syringes, the paste has a volume of between 15, 50, 100, or 500 μL and 1000, 2000, or 3000 μL ([0017]). Some embodiments of the present pre-loaded syringes are configured to dispense paste at a flow rate of at least about, about, or greater than 15 microliters per second (μL/s) ([0018]). In some embodiments of the present syringes, kits, and/or methods, the paste has a solids concentration of greater than 200 mg/mL. In some embodiments, the paste has a solids concentration of between 200 and 600 mg/mL ([0026]). For further example, paste can comprise a solids content (e.g., a mass of powder relative to a total mass of the paste) of between 30% and 40% (e.g., 35%) (e.g., greater than any one of, or between any two of 1,5, 10, 15,20,25,30,35,40,45,50, 55,60,65, 70, 75,80, 85, 90, 95, 99 or more%) ([0077]). A spray dried powder containing a monoclonal antibody (where the dried powder contained approximately 70% (w/w) protein) was used to prepare a high-concentration paste formulation by blending the powder with Miglyol 812 ([0095]). Donovan discloses that the composition comprises a pharmaceutically acceptable carrier such as a solvent, suspending agent or vehicle for delivering a compound of the present invention to the animal or human ([0041]).
Shen discloses a semi-solid delivery vehicle comprising a polyorthoester and an excipient (Abstract). Active agent includes pharmaceutically active agents which may be administered via injection such as subcutaneous, intramuscular, intradermal; therapeutic polypeptides such as insulin ([0046]).
Chen discloses compositions and methods of making high concentration protein formulations of a therapeutic protein (Abstract). The present invention satisfies the need for high concentration protein formulation comprising at least 200 mg/mL of a therapeutic protein ([0006]). the excipients in the high concentration protein formulation may include (i) a carbohydrate; (ii) an amino acid; and (iii) a non-ionic surfactant. The carbohydrate may be selected from sucrose, mannitol, sorbitol, dextran, maltodextrin, trehalose, or combinations thereof. The amino acid may be selected from proline, histidine, isoleucine, methionine, cysteine, glycine, arginine, lysine, L-leucine, Tri-leucine, alanine, glutamic acid, aspartic acid, L-threonine, 2-phenylamine, or combinations thereof. The non-ionic surfactant may be selected from polysorbate 20 (PS-20), polysorbate 28, polysorbate 40 (PS-40), polysorbate 65, polysorbate 80 (PS-80), polysorbate 81, polysorbate 85, poloxamer 181 ([0009]). As used herein, "therapeutic protein" includes any of proteins, recombinant proteins used in research or therapy, trap proteins and other chimeric receptor Fe-fusion proteins, chimeric proteins, antibodies, monoclonal antibodies, polyclonal antibodies, human antibodies, and bi specific antibodies. In another aspect, a protein can include antibody fragments, nanobodies, recombinant antibody chimeras, cytokines, chemokines, peptide hormones ([0066]). The formulation further includes buffering agents ([0076]).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to create a composition comprising a paste having a solid concentration of greater than about 350 mg/mL. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claims 2 and 6, solids concentration and a relative content of active pharmaceutical ingredient are discussed above.
Regrading claims 12-14, a peptide or protein therapeutic is discussed above.
Regarding claims 15-18 and 21, Donovan and Shen both disclose an injectable paste containing peptide or protein. One of ordinary skill in the art would immediately envisage experimenting with other pharmaceutically active agents such as different peptides and proteins.
Regarding claims 23-25, insulin is discussed above.
Regarding claims 28-29, as discussed above, one of ordinary skill in the art would experiment with different peptides or proteins via routine experimentation.
Regarding claims 31-32, monoclonal antibody is taught above.
Regarding claim 33, one of ordinary skill in the art would experiment with different peptides or proteins via routine experimentation.
Regarding claim 35, Chen teaches that the formulation is useful for the treatment and/or amelioration of a disease or disorder such as cancer ([0094]). One of ordinary skill in the art would immediately envisage experimenting with an anticancer agent.
Regarding claim 36, one of ordinary skill in the art would experiment with different peptides or proteins via routine experimentation.
Regarding claims 38-40, Chen discloses many therapeutic uses of the pharmaceutical formulations such as cancer, neurocognitive disorder, obesity, tuberculosis, and others ([0094]). One of ordinary skill in the art would routinely experiment with agents helpful for many different diseases and/or disorders.
Regarding claims 40-44, Chen discloses excipients as discussed above.
Regarding claims 47-48, Chen discloses excipients as discussed above.
Regarding claim 68, Chen discloses that spray drying is a technique that transforms a fluid state into a dried particulate form by spraying it into a hot drying medium. This micronized solid protein formulation can comprise a carbohydrate, an amino acid and a surfactant such as polysorbate ([0070]).
Regarding claim 69, Donovan discloses that a spray dried powder containing a monoclonal antibody was turned into a paste with Miglyol or capric triglyceride ([0095]).
Regarding claims 70-71, Donovan discloses that semi-solids such as gels in which the macromolecules are distributed are considered colloidal dispersion; the generally accepted size range for a substance “colloidal” is when particles fall between 1 nm and 0.5 micrometer ([0036]). One of ordinary skill in the art would recognize that semi-solids such as gels or paste could have ingredients with a mean particle size from 1 nm to 0.5 micrometer.
Regarding claim 72, Donovan discloses that the measured density of the paste was 1.12 g/mL ([0095]).
Response to Arguments
Applicant’s arguments filed 02/13/2026 have been fully considered but they are not persuasive.
On pages 15-17, applicant argues that the rejection fails to articulate a motivation to combine the art with a reasonable expectation of success. In the Office Action, the Examiner has failed to reasonably articulate why a skilled artisan would have been motivated to combine the cited art.
The instant application’s invention is a paste composition comprising active ingredients, excipients (saccharide, surfactant, amino acid or buffering agent) with non-solvent fluids. Reference Donovan discloses every element claimed except for the specific excipients. Chen is incorporated to teach that a composition comprising therapeutic protein routinely includes a saccharide, surfactant, amino acid or a buffering agent. Donovan discloses a method of making a paste – a spray dried powder containing a monoclonal antibody was used to prepare a high-concentration paste formulation by blending the powder with Miglyol 812 to yield a homogeneous two-phase suspension of mAb powder particles dispersed in a non-solvent ([0095]). Chen discloses that degradation of therapeutic protein in high concentration protein formulation is one of the major challenges faced during the development of these formulation. Proteins are less susceptible to chemical degradation in colloid state, compared to liquid state. As a result, the therapeutic protein contained in solid state affords higher stability to the high concentration protein formulation. In certain embodiments, the therapeutic protein in high concentration protein formulation is present as a micronized solid protein formulation, produced by spray drying ([0078]). One of ordinary skill in the art would at once envisage that a spray dried powder comprising a therapeutic protein can be turned into a paste. The motivation would be to increase the stability of the protein formulation.
On pages 17-18 of remarks, applicant argues the Chen’s formulation contains a viscosity-lowering agent. The instant claims do not exclude a viscosity-lowering agent.
On pages 19-20 of remarks, applicant argues that the paste formulation recited in amended claim 1 represents an “expansion and improvement” from the paste disclosed in Donovan. The instant application is a paste formulation that includes a saccharide, surfactant, amino acid, or a buffering agent. These are routinely used in a spray dried formulation comprising therapeutic protein as taught by Chen. The Examiner cannot determine the unexpected improvement from the paste disclosed in Donovan. Are the improvements achieved with a certain concentration of ingredients, excipients and/or non-solvent fluids? Are the improvements achieved with particular active ingredients? The Examiner encourages the applicants to further amend the claims to better align their scope with the improvements argued.
Conclusion
THIS ACTION IS MADE FINAL. 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 JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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