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 .
Applicant’s election without traverse of Group I, claims 1-6 in the reply filed on 19 May 2026 is acknowledged. The election/restriction requirement is deemed proper and is therefore made FINAL. An Action on the merits of claims 1-6 is contained herein.
Group II, claims 7-14, and Group III, claim 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Priority
This application claims foreign priority to CHINA 202310728657.9 filed 06/20/2023, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document, and certified English translation of the foreign priority document have been filed in the instant application.
The parent application CHINA 202310728657.9 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1-6 of this application.
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.
Claim(s) 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al (CN 104288280 A-machine English Translation, pages 1-8), in view of Wang et al (CN 102648905 A, machine English translation, pages 1-5) and further in view of Ouyang et al (CN 102657672A; machine English translation, pages 1-7) and Andremont et al (US 2012/0058936 A1).
Sun et al teaches an oil-in-water nanoemulsion composition comprising tulathromycin (abstract; paras 0011-0013, 0018; nanoemulsion as in claims1-3 and tulathromycin and water as in claims 1-3). The cosurfactant can be ethanol (para 0018-component in claims 1-3). The oil can be ethyl butyrate and ethyl acetate (para 0019; components in claims 1-3). The nanoemulsion greatly improves the solubility of tulathromycin (para 0025). The nanoemulsion has a particle size of 4nm (para 0026; limitation of claims 4-6). Sun teaches that surfactants that can be used are castor oil polyoxyethylene ether (40), etc. (para 0017). This renders the use of octylphenol polyoxyethelene(10) ether as a component (as in claims 1-3).
Sun’s composition does not contain kalii dehydrographolidi succinas, tributyl citrate, polyethylene glycol sorbitan monostearate, and the percentages of the components in the ranges as in claims 1-3.
Wang et al teaches a composition comprising kalii dehydrographolidi succinas and water (Abstract; para 0007; components recited in claim 1-3). These two components are included with a macrolide antibiotic Tylosin. However, this is a suggestion that kalii dehydrographolidi succinas can also be included with tulathromycin in the composition of Sun. According to Wang kalii dehydrographolidi succinas has antibiotic and anti-inflammatory effect (para 003). Hence the artisan would include this as a component in the composition of Sun.
Andremont et al’s invention is drawn to formulations comprising macrolides (Abstract). The macrolide can be tulathromycin (para 0091; component in claims 1-3). The formulation can be in the form of an aqueous liquid (para 0271; water as a component as in claims 1-3). Another component that can be included is sorbitan esters which are stabilizing agents. Tributyl citrate is also suggested as a component (para 0280; components in claims 1-3). Even though tributyl citrate is suggested as a coating plasticizer, one of ordinary skill in the art will recognize that it is an oil in the same class as the oil in Sun’s composition, and can also be included as a component along with polyethylene glycol sorbitan monostearate as in claim 1. The artisan can use the amounts disclosed in the prior art as starting point and include the components in the percentage ranges recited in claims 1-3.
It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). One of skill in the art would want to adjust the amounts of the components to obtain maximum beneficial effects for the use taught in the prior art.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) 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."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, tulathromycin in combination with the other claimed components is known individually in the art to give stable compositions which are useful for treating bacterial infections (Ouyang et al-Abstract).
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. One of ordinary skill in the art would be motivated to arrive at the claimed composition as an alternative stable composition for use in treating bacterial infections. Since kalii dehydrographolidi succinas has antibiotic and anti-inflammatory effect as taught by Wang, including it as a component with tulathromycin would give a highly effective combination for use in treating bacterial infections. There is a reasonable expectation of success that the claimed composition would be highly stable and have better effect in view of Sun et al (para 0025).
Conclusion
1. Elected claims 1-6 (Group I) are rejected.
2. Group II, claims 7-14, and Group III, claim 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/ Primary Examiner, Art Unit 1693
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