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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of claims 54-58, 60, and 69-74 and species: a lyophilized pharmaceutical composition comprising sovateltide, trisodium citrate, and mannitol, total impurities are not more than 2%, a 0.9% sodium chloride solution, in the reply filed 06/26/2026 is acknowledged.
Claims 59, 61-68 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 06/26/2026.
Claims 54-58, 60, and 69-74 are now under consideration in the instant Office Action.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 54-58, 60, and 69-74 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chaudhary et al. 2008 (WO 2008/075379 A1, in IDS filed 12/29/2025).
Chaudhary et al. teaches a stable formulation for the enhanced delivery of diagnostic agents to solid tissues in safe dosage forms, wherein the formulation comprises an endothelin B receptor agonist and various stabilizers in specific ratios, see reference’s claim 1. The endothelin B receptor agonists can be “synthetic analogs BQ3020 and IRL1620” which are the most widely used selective synthetic agonists to characterize ETB receptors, see page 2. Chaudhary et al. teaches that “the stable formulation comprises of an endothelin compound which is a known peptide IRL1620 along with excipients Mannitol, Sodium Citrate preferably as dihydrate in fixed amounts using water for injection as vehicle” and that “the composition is a lyophilized formulation stored in a glass vial using halogenated stopper and a flip off aluminum seal formulated in aseptic conditions for administration in mammals including human”, see page 6. This meets the limitations of instant claim 54 wherein the lyophilized pharmaceutical composition comprises sovateltide, trisodium citrate, and mannitol and instant claim 55 wherein the composition is a lyophilized powder. This also meets the limitations of instant claim 69 wherein a container is used to contain the lyophilized composition and instant claim 74 wherein the container is a vial.
Chaudhary et al. also teaches that the “amount of IRL1620 in the composition is 0.10 μg to 10.0 μg per kg body weight, more preferably in the range of 0.75 μg to 7.0 μg per kg body weight, most preferably in the range of 0.5μg to 3.0/μg per kg body weight”, see page 6. This meets the limitations of instant claim 56 wherein the sovateltide concentration can be adjusted within formula to achieve 0.01% to about 0.02% w/w. This also meets the limitations of instant claim 70 wherein the total amount of sovateltide in the vial reaches 30.0 μg. Chaudhary et al. discloses lyophilized pharmaceutical compositions containing the endothelin B receptor agonists, sodium citrate, and mannitol. In experiment 8, Chaudhary et al. recites adding sodium chloride to the reconstitution of the lyophilized powder, see page 8. Chaudhary et al. lists the components of the formulation as follows in the reference’s claims 6-7:
concentration of the peptide ranges from 0.1 to 10 microgram / kg body weight.
concentration of active ingredient ranges from .01 mg/vial to .05 mg/vial of the formulation.
concentration of mannitol ranges from 25mg to 75mg/vial of the formulation.
Sodium citrate (Dihydrate) 10 mg to 45 mg of the formulation to be reconstituted with water for injection before administration.
This meets the limitations of instant claims 57, 71, and 72 wherein the trisodium citrate and mannitol concentrations can be narrowed down to 50 mg trisodium citrate and 160 mg mannitol based upon a wider range taught by the prior art to fit a particular embodiment, instant claim 60 wherein the composition comprises sodium chloride, and instant claim 73 wherein the container comprises water.
Chaudhary et al. also teaches a process for making the composition of formulation of claim 1 comprising the lyophilization of the active ingredient along with suitable stabilizers and a process for manufacture of formulation as described herein above, see reference’s claims 8-9.
With respect to instant claim 58, these limitations are drawn to inherent properties of the formulation itself. Since Chaudhary et al. teaches the instantly claimed composition, these properties are inherent to the composition itself. Chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)). Thus, absent evidence to the contrary, these properties are inherent to such compositions in Chaudhary et al. as those compositions meet all of the structural elements of the claims.
Therefore, claims 54-58, 60, and 69-74 are anticipated by Chaudhary et al.
Conclusion
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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