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 .
DETAILED ACTION
Claims 3-25, 27 and 28 are pending in the current application.
Claims 9-25 and 28 are withdrawn from consideration (see discussion, below).
Claims 3-8, 21-23 and 27 are examined in the current application.
Election/Restrictions
Claims 9-25 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 25th 2025.
Applicant's election with traverse of claims 3-8, 21-23 and 27 in the reply filed on August 25th 2025 is acknowledged. The traversal is on the grounds that Greeves fails to disclose the special technical feature “phospholipid composition comprising phosphatidylcholine and an anionic phospholipid compound”. This is not found persuasive because Greeves discloses in the bottom of page 4 to the top of page 5 and in claim 9 of phospholipid composition comprising phosphatidylcholine and an anionic phospholipid compound.
The requirement is still deemed proper and is therefore made FINAL.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 3-8, 21-23 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Greeve et al. (WO 2008/113421 A1) in view of NPL “Lekithos” (from https://lekithos.com/products/organic-sunflower-lecithin-liquid?variant=40467331645540).
Regarding claims 21, 22, 27, 3, 4 and 6-8: Greeve discloses a method of preparing an oil-in-water emulsion to be used for parenteral (i.e., subcutaneous) administration by homogenizing an aqueous and an oil phase using a phospholipid composition comprising phosphatidylcholine and an anionic phospholipid compound that is phosphatidylglycerol (e.g., 1,2-dimyristoyl-sn-glycero-3-phophorylglycerol (‘PMPG’)), or phosphatidylethanolamine (see Greeve paragraphs 1, 4 and 5 on page 4, and paragraphs 1 and 2 on page 5, paragraphs 1 and 2; claim 9 on page 3). Greeve discloses sunflower lecithin may be one of the sources of the phospholipid composition (see Greeves paragraphs 4 and 5 on page 4), which is known to comprise about 2100 mg of phosphotidylcholine in about 15g (see Lekithos page 1), which meets the phosphatidylcholine content in claim 7.
Regarding claim 5: Greeve discloses the phospholipid composition may comprise a phospholipid compound (e.g., phosphatidylcholine) and an anionic phospholipid compound (e.g., PMPG) or any combination thereof (see Greeve claim 9 on page 3), which encompasses the claimed ratio.
Regarding claim 23: Greeve discloses autoclaving the resulting composition (see Greeve paragraph 1 on page 14; Embodiments section on page 17).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASSAF ZILBERING whose telephone number is (571)270-3029. The examiner can normally be reached M-F 8:30-5:00.
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/ASSAF ZILBERING/Examiner, Art Unit 1792