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’s election without traverse of Group I, (drawn to pharmaceutical compositions comprising propofol), in the reply filed on 04/14/2025 is acknowledged.
Claims 1-20 are pending of which claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 1, 4-6, 8-11, 13, 15-18 have been examined on the merits.
New Grounds of Rejection due to claim amendments
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office
action.
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.
Claims 1, 4-6, 8-11, 13, 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. CN101675917A (cited on the IDS of 05/16/2025) in view of Meadows et al. (WO 03/017977) in further view of Patel et al., EP 1158959B1 (cited on the IDS of 05/16/2025), Date et al. AAPS PharmSciTech 9, 138–145 (2008). All references are being made to the English translation (machine generated). The Chinese version can be found at the end of the English translated version.
Regarding claims 1, 4, 8, 13 and 15, Wang (page 1-2) teaches a method of preparing propofol self-micro-emulsifying composition:
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While Wang does not explicitly use the phrase surfactant and cosurfactant, however, Wang nonetheless teaches components that fall within the scope of the claimed invention.
For example, Wang (page 4, Example 4) teaches the following composition, reading on instant claims 1, 4, 8, 13 and 15:
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Wang, however, does not explicitly teach ratio and UV absorbance at 600 nm.
However, Meadows (page 16, Example 3) teaches a similar propofol composition (Diprivan) in water at 1% solution (0.1 g of propofol composition in 10 ml of water). The UV absorption was measured at around 272 nm, but Meadows does not provide a data for turbidity. Given the combined teachings of Wang and Meadows teaches the same propofol composition and ratio comparable to the instant claims, thus, it would have been expected that turbidity would also be the same. Applicants are reminded that the Office does not have the facilities and resources to determine that the process taught by the prior art would result in the same properties as indicated in the claimed invention. The burden is on Applicants to show that the compositions are not the same or substantially similar. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112(III).
This conclusion is further supported by Date (page 139):
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Regarding mixing time, Date (page 139) discloses steps of mixing propofol composition that include both mixing and an equilibrating period of about 30 min at 25ºC before further analysis.
Wang, however, does not explicitly teach hydrophilic-lipophilic balance (HLB).
However, Patel (page 8, Table 5; page 17, Table 15; respectively) teaches
PEG-35 castor oil (HLB =11), and Poloxamer 124 (HLB = >7), reading on instant claim 3, 12. Patel (page 9, line 5; line 55, respectively) further teaches Labrafil Ml944CS and Polyglyceryl-3 oleate with HLB < 10.
It would have been prima facie obvious that a POSITA would modify the composition of Wang, which contains a triglyceride, using the techniques of Patel, Meadows and Date, thereby overcoming triglyceride challenges, to arrive at the claimed invention. One would have been motivated to do so because Patel teaches a free-triglyceride formulation and the disadvantages of having triglycerides in a propofol formulation, as taught by Wang. One would have had a reasonable
expectation of success, as Wang teaches various propofol and surfactant combination, while
Patel teaches surfactants can combine with a wide range of therapeutic agents.
Note: The claimed invention lacks the required level of inventiveness and is an obvious combination or modification of existing knowledge. Therefore, it involves the use of known technique to improve similar devices (methods, or products) in the same way. See MPEP 2141(III).
Regarding claims 5-6, 9, 10, and 11, Wang (page 1-2 and 4-5) teaches the following regarding surfactant and cosurfactant, although Wang uses different terminology, reading on the instant claims 5-6, 9, 10, 11:
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Regarding claim 16-17, Wang teaches a propofol composition comprising of propofol 1 to 15% and surfactant of 10 to 70%. Wang, however, does not teach surfactant between 75-90%.
However, Date (page 139), as applied to claim 1 above, teaches flexibility of surfactant ratios in propofol formulation. This indicates that the surfactant concentration can be adjusted relative to propofol concentration to achieve stable formulation. For example, Date (page 139) discloses a mixture of propofol and surfactant, adding 100 mg of propofol 1 g of surfactant which would lead to a surfactant constituting about 90% (w/w) of the mixture. Therefore, it would have been obvious to a POSITA to modify the teachings of Wang in view of Date to arrive at the claimed invention, because Wang teaching propofol at the range of 1-15%, thus, a POSITA would reasonably expect surfactant contribution to fall between 85-90% (w/w). Furthermore, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP 2141.05(II).
Regarding claim 18, Wang (page 3, claim 14) teaches the following:
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Response to Argument
Applicant argues that Patel intends to avoid the formation of a microemulsion, as a result, does not provide a reasonable expectation of success for applying condition from Wang that teaches microemulsion. Applicant’s argument is not persuasive, because Patel does provide support for the use of emulsion or microemulsion as a stable and effective delivery system. For example, Patel (page 3, [0008]) teaches the following
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Patel (page 24, [0081]) also teaches the following
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In fact, Patel does not teach avoidance of microemulsion but rather demonstrates how to formulate them more effectively. Thus, Patel provides both motivation and expectation of success by highlighting the importance of optimizing the system and the functional advantages of producing smaller or more uniforms particles.
Applicant argues that Patel intends to avoid problems associated with emulsions or microemulsions, while Wang teaches emulsion and microemulsions system, thus indicating the references are incompatible. Applicant’s argument is not persuasive, because: first, the fact that both references use similar surfactants and cosurfactants indicate overlap in concept. Second, this demonstrates an effort to optimize the formulation technology and address issues seen in conventional microemulsion or emulsion. This optimization, such as reducing particle size and improving stability, are one of the key goals in microemulsion formulation. Thus, rather than being incompatible, the references align in seeking better solution, contradicting the Applicant’s assertion that the references are fundamentally incompatible.
Conclusion
No claims are allowed.
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 PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622