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 the synthetic HDL nanoparticle compositions of Claims 84-91 in the reply filed on 16 December 2025 is acknowledged.
Status of the Claims
Claims 84-104 are pending.
Claims 92-104 are withdrawn from consideration as directed to non-elected inventions.
Claims 84-91 are presented for examination and rejected as set forth below.
Priority
The instant application is a National Stage entry of International application PCT/US2021/062779 filed 10 December 2021, which claims the benefit of Provisional US application 63/124,403 filed 11 December 2020.
Claim Interpretation
Applicants Claims are directed to nanoparticles containing any of a Markush-type listing of alternative apolipoproteins, which in dependent claim 87 is narrowed to specifically any apolipoprotein corresponding to any of the peptides identified as SEQ ID NOs 1-371, combined with at least one lipid selected from among a second Markush-like listing of alternative lipids, which in dependent claim 86 is narrowed to one where a neutral, positively charged, or negatively charged phospholipid is required. Any of the phospholipids recited by Claim 84 will be presumed to address these limitations. See MPEP 608.01(n)(III)(indicating that a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed; a claim in dependent form shall be construed to incorporated by reference all the limitations of the claim to which it refers.). Claims 85 and 91 include limitations that the nanoparticles have a particular molar ratio of apolipoprotein to lipid, or require the particles have a particular size. Claim 88 specifies a weight ratio of apolipoprotein to lipid component. Claim 89 includes a limitation specifying, among others, defined concentrations of cholesterol be present in the nanoparticle, with Claim 90 indicating anti-inflammatory agents should be included.
Claim Rejections - 35 USC § 112(b)
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 84-91 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 84 includes the broad limitation “diphosphatidyl glycerols,” and the claim also recites “such as dimyristoylphophatidylglycerol…” which is the narrower statement of the limitation. In a similar manner, Claim 91 includes broad, and multiple narrower range iterations of endotoxin units, sHDL purity, sHDL homogeneity, nanoparticle size, or degrees to which the HDL apolipoprotein is complexed. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For purposes of compact prosecution, the broadest limitation will be construed as governing. See Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005)( During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification”).
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.
Claim 84-86 and 88 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yuan (CN110123761)(machine translation provided).
Yuan describes a nanoparticle containing DMPC combined with apolipoprotein analogue peptide 5A corresponding to the “HDL apolipoprotein mimetic” of the present claims, having a particle size of 13nm and a mass ratio of peptide to phospholipid of 1:1 and 1:5. (Pg.6)
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 84-91 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]. Specific lipoproteins recited as useful in the nanoparticles described are apolipoprotein mimetics, more specifically ApoA-1 mimetics of any of SEQ ID Nos 1-336, which includes the peptide SEQ ID NO 1, which corresponds to peptide SEQ ID NO. 3 of the instant claims. [0014; 0020; 0026; 0360]. Moon indicates that the nanoparticles should have an average particle size of between 6-70nm. [0018]. Each of the DPPC and DOPE-PDP phospholipids of Claim 84 are described by Moon as suitable phospholipids used as the lipid component of the nanoparticles, as is the cholesterol recited by Claim 89. [0019; 0130-33]. While no particular limitations concerning the concentration of cholesterol are particularly identified by the teachings of Moon, it must be remembered that generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where 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.). Where, as here, each of a variety of phospholipids and cholesterol, as well as combinations thereof, are described by the reference as suitable lipids for use in formulating sHDL lipoprotein nanoparticles, the record at present supports the conclusion that the particular concentrations of cholesterol recited by Claim 89 would be prima facie obvious as nothing more than the result of routine optimization. Moon indicates that the sHDL nanoparticles 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 a1:2 weight ratio of apolipoprotein to lipid, 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]. While not recited in the same terms as Claim 91, the Examiner considers a “homogeneous” size distribution, combined with the advantages associated with the small and tunable sizes of nanoparticles advocated by Moon sufficient to address the size limitations of Claim 91. Moon indicates that additional active agents, including the anti-inflammatory agents of Claim 90, may be included in the compositions. [0265-67].
Moon therefore suggests combining apolipoproteins such as the peptide identified in the present claims as SEQ ID NO 3 with lipids including cholesterol as recited in any concentration in Claim 89 and at least the phospholipid DPPC of Claim 84 to provide uniformly sized nanoparticles of about 5 or 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. 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 3 with lipids including cholesterol as recited in any concentration in Claim 89 and at least the phospholipid DPPC of Claim 84 to provide uniformly sized nanoparticles of about 5 or 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 from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Conclusion
No Claims are allowable.
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.
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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