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 .
Election/Restrictions
Applicant elects Group I (claims 1-6 and 9) without traverse, claims 7, 8, and 11-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The election is made FINAL.
Summary
Receipt of Applicant’s Preliminary/Remarks and Amendments filed on 11/26/2025 is acknowledged. Claims 1-6 and 9 are pending.
Claim 10 have been have been cancelled.
Claims 4-9 have been amended. Claims 7-8 are withdrawn per election restriction.
Claims 1-6 and 9 are pending and under examination in this application.
Priority
The current application filed on 10/05/2023 is a 371 of PCT/CN2022/080019 filed 03/09/2022, which in turn claims priority to patent application CN202110387270.2 filed on 04/08/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/05/2023 is in compliance with the provisions of 37 CFR 1.98. Accordingly, the information disclosure statements has been considered by the examiner. Signed copies have been attached to this office action.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims1-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ye (WO 2017036408 A1).
Ye teaches sustained-release suspension formulation for ropivacaine comprising (A) ropivacaine; B) a carrier comprising one or more surfactants, one or more suspending agents, one or more fillers, one or more preservatives, one or more isotonic agents, one or more buffers and C) water for injection (page 3, top ¶).
Regarding claims 1-4, as noted above, Ye teaches ropivacaine formulation comprising suspending agents, isotonic agents, surfactants and the primary suspension of ropivacaine is mechanically ground or homogenized to reduce the particle size of ropivacaine to the desired level, such as 0.1 to 50 microns, and to prepare a sterile ropivacaine suspension formulation having the desired average particle size (page 5, ¶ 3) and isotonicity agent mannitol and sodium chloride (page 2, bottom page).
Regarding claim 5, Ye teaches the suspension preparation according to the present invention is preferably in the range of 1 to 40% by weight, more preferably 2 to 20%, still more preferably 2 to 8% by weight of ropivacaine (page 3, ¶ 5), surfactant in the amount of 0.01 % to 20 % (page 4, ¶ 2), isotonicity adjusting agent in the amount 0.05 % to 20 % (mannitol or sodium chloride) (page 4, ¶ 8), and 0.1 to 2% of the suspending agent (page 2 middle, ¶ C) and the suspending agent is selected from the group consisting of carboxymethylcellulose or a sodium salt thereof, hydroxy-propylcellulose, methylcellulose, hydroxyethylcellulose, hydroxypropyl Methylcellulose, sodium hyaluronate and polyvinylpyrrolidone, preferably sodium carboxymethylcellulose and polyvinylpyrrolidone; said surfactant is selected from the group consisting of polysorbate 20 (Tween-20), polysorbate 40 (Tween-60), Polysorbate 60 (Tween-60), Polysorbate 65 (Tween-65), Polysorbate 80 (Tween-80), Polysorbate 85 (Tween-85) , Polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil, lecithin, polyvinylpyrrolidone, polyethylene glycol, polyoxyethylene and polyoxypropylene ethers (poloxamer 188 and poloxamer 407, etc.) 15-hydroxystearic acid polyethylene
glycol ester, preferably Tween-20, Tween-80, 15-hydroxystearic acid polyethylene glycol and poloxamer 188; the filler is selected from the group consisting of mannitol, sucrose Maltose, xylitol, lactose, glucose, starch, sorbitol or the like, preferably mannitol and sucrose; said preservative is selected from the group consisting of benzoic acid, benzyl alcohol, butylated hydroxytoluene, butylated hydroxytoluene, Chlorobutanol, gallate, hydroxybenzoate, EDTA, phenol, chlorocresol, m-cresol, benzethonium chloride, myristyl-γ-methylpyridine chloride, mercaptoacetate, Thiomersal, preferably benzyl alcohol and hydroxybenzoate; said isotonicity agent is selected from the group consisting of mannitol, sorbitol, sodium chloride, glucose, sucrose, fructose, lactose,
preferably mannitol, sodium chloride and glucose; The buffering agent is selected from the group consisting of phosphates, acetates, citrates or TRIS buffers, preferably phosphates (2nd page of Description, Bottom page).
Regarding claim 6, Ye teaches to adjust the pH of the suspension to a range of 6 to 8.5 (page 4, ¶ 4-5).
Regarding claim 9, Ye teaches Freeze-drying (page 5, ¶ 5-6).
Ye does not teach within a single embodiment in order to anticipate but renders obvious the instant claims. As such it would be obvious at the time the invention was filed to rearrange the components of ropivacaine, suspending agent, iso-osmotic adjusting agent, surfactant, pH adjusting agent and optimize the median particle size D50 of the suspension injection to the desired range within 1 µm to 40 µm and obtain a composition as claimed. A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. Where, as here, the specific combination of features claimed is disclosed within the broad teachings of the references but the reference does not disclose the specific combination of variables (for example, the specific median particle size D50 of the suspension injection in 1 µm to 40 µm, 3 µm to 40 µm, 5 µm to 20 µm), in a specific embodiment or in a working example, “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). However, "when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious". KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious", the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is ... a person of ordinary creativity, not an automaton." Id. at 1742. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to rearrange the disclosed elements and embodiments of Ye, to include an example of the specific median particle size D50 of the suspension injection, to prepare the claimed composition. Such a rearrangement by a person of ordinary skill in the art who is not an automaton to yield the instantly claimed compositions and methods is within the purview of the ordinary skilled artisan upon reading Ye, as cited above, and would yield predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0323. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615