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 .
Claim Objections
Claims 1 and 9-11 are objected to because of the following informalities:
The figures of the compounds are faded and not clear. Examiner notes that where the compound is named, the appears to be redundant. Appropriate correction is required.
Claim Rejections - 35 USC § 101 / 35 USC § 112
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because they are directed to a “Use”. A “Use” appears to be method subject matter, but there is no active step.
Claims 10 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims are unclear as they appear to be directed to a method, but have no active step.
For purposes of examination, the claims will be interpreted as composition claims with the “Use” defining an intended use.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3, 6, 8, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al (Chemical components, pharmacological properties, and nanoparticulate delivery systems of Brucea javanica. International Journal of Nanomedicine, 8, 85–92. https://doi.org/10.2147/IJN.S31636), as evidenced by Zhang et al (Front Pharmacol. 2022 Mar 18;13:853119. doi: 10.3389/fphar.2022.853119).
Chen et al discloses encapsulating Brucea javanica oil in nanoparticlulate drug delivery systems, specifically liposomes to improve poor solubility of dissolving drugs (see Liposomes section).
Zhang et al evidences that bruceantin is a component of Brucea javanica oil. Thus, while Chen et al did not recognize all the active compounds encapsulated at the time, where of Brucea javanica oil was encapsulated, bruceantin was an encapsulated component.
Claim Rejections - 35 USC § 103
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (Chemical components, pharmacological properties, and nanoparticulate delivery systems of Brucea javanica. International Journal of Nanomedicine, 8, 85–92. https://doi.org/10.2147/IJN.S31636), as evidenced by Zhang et al (Front Pharmacol. 2022 Mar 18;13:853119. doi: 10.3389/fphar.2022.853119), in view of Shanley et al (US 2004/0254635).
Chen et al and Zhang et al are discussed above, but do not teach the specific liposome components of instant claims 4 and 5 or the size of instant claim 7.
Chen et al further teaches the nanoparticles are seized from 10nm to 100nm, but do not disclose the size of the liposomes.
Shanley et al teaches it was well known in the art to formulate liposomes using known lipids, including DPPE and glycerol monolaurate (¶ 124).
It would have been obvious to one of ordinary skill in the art to formulate the liposomes of Chen et al using any known lipids suitable for encapsulating the active, such as taught by Shanley et al. When formulating the liposomes, the size of the liposomes will inherently flow form the formation of the liposomes and the lipids used to encapsulate the active.
Double Patenting
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,295,938 in view of Chen et al (Chemical components, pharmacological properties, and nanoparticulate delivery systems of Brucea javanica. International Journal of Nanomedicine, 8, 85–92. https://doi.org/10.2147/IJN.S31636). ‘938 is directed to a method for treating castration-resistant prostate cancer by administering a pharmaceutical composition which may include bruceantin, but does not claim nanoparticles or liposomal delivery. Chen is discussed above for teaching the ability to administer compounds from Brucea javanica via nanosized liposomes.
Allowable Subject Matter
Claims 9 is free of the prior art and will be allowable when the ODP rejection is resolved.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri 9:30am-6:30pm + mid-day flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
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