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 .
Status of the Claims
Claims 84-86 and 88-104 are pending.
Claims 92-104 are withdrawn from consideration as directed to non-elected inventions.
Claims 84-86 and 88-91 are presented for examination and rejected as set forth below.
Claim Interpretation
Applicants Claims are directed to nanoparticles containing an apolipoprotein A-I mimetic peptide having the amino acid sequence of SEQ ID NO 4, combined with a lipid component which includes DMPC, having an average particle size between 7-12nm, and a ratio of peptide to lipid within the range of about 1:1.5 and 1:3, which in dependent Claim 88 is narrowed to a ratio of about 1:2. Claim 85 includes limitations that the nanoparticles have a particular molar ratio of apolipoprotein to lipid. Claim 86 adds sphingomyelin to the lipid component. Claim 89 includes a limitation specifying the particles possess certain degrees of purity. Claim 90 indicates anti-inflammatory agents should be included. Claim 91 indicates that the composition lacks certain impurities, or provides a certain degree of HDL apolipoproteins as complexes.
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 84-86 and 88-91 are rejected under 35 U.S.C. 103 as being unpatentable over Moon (U.S. PGPub. 2018/0078625).
Moon describes nanoparticles complexed with biomacromolecule agents comprising a synthetic high density lipoprotein, combined with a phospholipid. (Abs.); [0012]. Moon describes a specific composition which provides the protein having the claimed SEQ ID NO: 4 in a lipid nanoparticle comprising DMPC which has a particle size of 10.6±0.2 nm. “Fig. 13”; [0076; 0125 “Table 1”]. Indeed, Moon repeatedly exemplifies the use of apolipoprotein 22A, corresponding to the presently claimed SEQ ID NO: 4. [0125; 0292-93] Moon indicates that the sHDL nanoparticles may optionally contain additional phospholipids including the sphingomyelin of Claim 86, and should have a molar ratio of phospholipid to apolipoprotein of 2:1, addressing Claim 85. [0132]. A particular embodiment of a apolipoprotein loaded nanoparticle is described as possessing a 1:2 weight ratio of apolipoprotein 22A to lipid component comprising DMPC, addressing the requirements of Claim 88. [0293]. Moon indicates that the nanoparticles may have a diameter of about 5nm or about 10nm, specifically advocating that the nanoparticles be subjected to size exclusion chromatography to provide a homogeneous preparation while also indicating that the extremely small and tunable sizes of the particles more effectively drain to lymph nodes. [0133-35; 0269]. Moon indicates that additional active agents, including the anti-inflammatory agents of Claim 90, may be included in the compositions. [0265-67]. As Moon specifically uses endotoxin-free water, the absence of endotoxins required by Claim 91 is presumed. [0293-94; 0331-32].
Moon therefore suggests combining apolipoproteins such as the peptide identified in the present claims as SEQ ID NO: 4 with lipids including each of DMPC and sphingomyelin to provide uniformly sized nanoparticles of about 10nm with a molar ratio of lipoprotein to lipid of about 2:1, a 1:2 weight ratio of apolipoprotein to lipid, and an antiinflammatory agent which lacks endotoxins. This is because “[w]hen 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 at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have combined apolipoproteins such as the peptide identified in the present claims as SEQ ID NO: 4 with lipids including each of DMPC and sphingomyelin to provide uniformly sized nanoparticles of about 10nm with a molar ratio of lipoprotein to lipid of about 2:1, a 1:2 weight ratio of apolipoprotein to lipid, and an antiinflammatory agent which lacks endotoxins from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Response to Arguments
Applicant’s arguments with respect to the rejections of former claims 84-91 as indefinite under 35 U.S.C. 112(b) and of Claims 84-86 and 88 as having been anticipated under 35 U.S.C. 102(a)(1) by the teachings of Yuan have been fully considered and, in view of the amendments to the claims presented on 11 May 2026, are persuasive. These rejections of remaining Claims 84-86 and 88-91 have been withdrawn.
Applicant's arguments filed 11 May 2026 concerning the obviousness of remaining Claims 84-86 and 88-91 have been fully considered but they are not persuasive.
The examiner first notes that the previous rejection of Claims 84-91 as obvious under 35 U.S.C. 103 was solely over the teachings of Moon, not the combined teachings of Yuan and Moon. Moon indeed discloses, and in a representative embodiment, nanoparticles possessing apolipoprotein having the protein comprising the amino acid SEQ ID NO:4, which is combined with a lipid component possessing DMPC, and having a particle size of 10.6±0.2 nm. “Fig. 13”; [0076]. As set forth above, each of the protein 22A (SEQ ID NO: 4), DMPC, and sphingomyelin are described as usefully incorporated into apolipoprotein nanoparticles, rendering obvious the present claims.
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
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 SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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