DETAILED ACTION
A non-final Office action was mailed September 4, 2025 (“Office Action”).
Applicant’s reply to the Office Action was received December 10, 2025 (“Reply”).
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 1–4, 6–11, 13, 16, 18, 19, and 21–25 are pending. Claim 7 is amended.
Claims 5, 12, 14, 15, 17, and 20 are canceled.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code and/or text providing the basis for non-statutory double patenting rejections not included in this action are set forth in the Office Action.
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Claim Objections
Claims 4 and 11 are objected under 37 C.F.R. § 1.75 as being a substantial duplicate of claims 6 and 13, respectively.
When multiple claims in an application are duplicates or are so close in content that they cover the same thing, despite a difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Response to Arguments
Applicant did not argue against the objections; they are maintained.
Claim Rejections - 35 U.S.C. § 103
Claim 7 is rejected under 35 U.S.C. § 103 as being unpatentable over US 8,598,186 (“Tavares”) in view of Berge et al., J. Pharmaceutical Sciences (1977), 66(1), 1–19 (“Berge”) and US 10,988,479 (“Schneider”).
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Tavares discloses trilaciclib and salts thereof. (Tavares, col. 81, claim 1).
Tavares discloses at least one example of a trilaciclib salt: HCL salt. (Id., 70:1–22).
Berge discloses the most common FDA-approved salts used in the pharmaceutical art. See, e.g., Table I, p.2 (listing 53 anions, including hydrochloride and citrate).
Schneider discloses trilaciclib, salts thereof, and polymorphs thereof, including a crystalline form of trilaciclib dihydrochloride. (Schneider, 2:8–40).
Schneider discloses “pharmaceutically acceptable salts” include hydrochloric acid and citric acid salts. (Id., 24:31–25:2).
Ascertaining the differences between the prior art and the claims at issue
The cited references do not disclose a citric acid salt of trilaciclib in crystalline form.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application does not include evidence showing the citric acid salt of trilaciclib has unexpected properties relative to the HCl salt of trilaciclib.
The question of obviousness
Based on the above factors, it would have been obvious for a person having ordinary skill in the art prior to the filing of the instant application to combine the teachings of Tavares, Berge, and Schneider to arrive at the claimed citric acid salt of trilaciclib in crystalline form because all the claim elements were known in the art: Tavares discloses a pharmaceutical salt of trilaciclib, Schneider discloses a crystalline form of a trilaciclib salt, and Berge discloses citric acid as one of the most common FDA-approved anions for pharmaceuticals.
One of ordinary skill in the art would have been motivated to modify Tavares to improve one or more properties of trilaciclib. There would have been a reasonable expectation of success at arriving at the claimed invention because preparing and using pharmaceutical salts of active ingredients is common in the art and well within the skill and knowledge of one skilled in the art, as evidenced by the disclosure of the HCl salt of trilaciclib in Tavares, and preparing and using specific crystalline forms of pharmaceutical salts of trilaciclib were known and within the skill and knowledge of one skilled in the art.
Response to Arguments
Applicant argues, “the claimed crystallin salt exhibits advantageous properties that support a finding of non-obviousness . . .” (Remarks, p.7). Applicant states: “Applicant has conducted a solubility test comparing . . .” (Id.).
Applicant does not assert the evidence of unexpected results obtained from the solubility test is present in the instant specification. Accordingly, the evidence is new allegations of fact. The introduction of new factual evidence must be submitted in connection with a declaration signed by a person having firsthand knowledge of the facts. Allegations of facts by Applicant’s representation is considered attorney argument, which is not given any evidentiary weight.
Double Patenting
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1–11 of copending App. No. 18/837,960 (reference claims).
18/030,547
18/837,960
A Trilaciclib citric acid salt in crystalline form.
Crystalline Trilaciclib hemicitrate salt.
Although the claims at issue are not identical, they are not patentably distinct from each other because they cover the same compound (Crystalline trilaciclib hemicitrate salt). Thus, an infringer of a patent granted based on the reference claims would also be an infringer of the instant claim 7.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant did not argue against the rejection; it is maintained.
Allowable Subject Matter
Claims 1–3, 6, 8–10, 13, 16, 18, 19, and 21–25 are allowable.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 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 C.F.R. § 1.17(a)) pursuant to 37 C.F.R. § 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.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.M.N./Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623