DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 11/18/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments with respect to the instant claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) 1, 7, 10-11, 13-14, 17, 35-36 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Lam et al (US 2013/0164369A1).
Lam taught a nanodisc without a membrane scaffold protein [abstract and claim 1], encapsulated with a drug agent, and covalently bound with a targeting antibody or fragment thereof [0081-0082, 0099]. The nanodiscs comprised lipids selected from mixtures of DPPC (e.g., reads on long-chain phospholipid) and DOPC (e.g., reads on short-chain phospholipid) [claims 1, 9, 10 and ¶ 0075].
Claim 1 is rendered prima facie obvious over the teachings of Lam, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., nanodisc, encapsulated therapeutic agent, mixture of long and short chain phospholipids, targeting antibody) were known in the prior art (e.g., Lam) and one skilled in the art could have combined the elements as claimed, by known methods with no change in their respective functions, and the combination would yield nothing more than predictable results (e.g., a nanodisc) to one of ordinary skill in the art. MPEP 2143.A.
Lam reads on claims 1, 7 and 54.
Claims 10-11 and 13 are rendered prima facie obvious because Lam taught DMPG and DSPE-PEG2000 [0075].
Claim 14 is rendered prima facie obvious because Lam taught DPPG and DPPC [claim 10]. The molar percentage (mol %) was from about 0% to about 10% of the total lipid present in the nanodisc [0079].
The instant claim 14 recites a mole to mole ratio of 0.01 to 0.1.
Lam taught a mole to mole ratio of from about 0% to about 10%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
The instant claim 17 is rendered prima facie obvious because Lam taught a diameter from about 25 nm to about 900 nm [0083].
The instant claim 17 recites a diameter of 30-40 nm.
Lam taught a diameter of 30-40 nm. A prima facie case of obviousness exists because of overlap, as discussed above.
Claims 35-36 are rendered prima facie obvious because Lam taught a therapeutic (Amphotericin, AmB) agent to lipid (phospholipid, PL) ratio of 1.25:2.5 or 1.25:5 [see Table 1].
The instant claim 35 recites a therapeutic agent to lipid ratio of 1:2 to 1:20.
The instant claim 36 recites a therapeutic agent to lipid ratio of 1:4 to 1:20.
Lam taught a therapeutic agent to lipid ratio of 1.25:2.5 or 1.25:5. A prima facie case of obviousness exists because of overlap, as discussed above.
Claims 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lam et al (US 2013/0164369A1), in view of Peking University (CN 106834355A).
The 35 U.S.C. 103 rejection over Lam was previously disclosed.
Additionally, Lam taught cationic lipids at ¶s [0020,0074, 0077].
Although Lam generally taught short chain phospholipids (e.g., DOPC), as previously discussed, Lam was not specific DHPC, as recited in claims 9 and 15.
Peking University taught composite lipid nanodiscs composed of cationic lipids and short-chain lipids, including DHPC [abstract and claims 4 and 8].
Since Lam taught nanodiscs, generally formed of short-chain phospholipids, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Lam, DHPC, as taught by Peking University. The ordinarily skilled artisan would have been motivated to form the nanodisc, as taught by Peking University, as the abstract and at claims 4 and 8.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, it is prima facie obvious to select DHPC for incorporation into a composition, based on its recognized suitability for its intended use as a short-chain phospholipid, in the formation of nanodiscs, as taught by Peking University.
The instant claim 15 recites ([DPPC])+([DPPG])/[DHPC] at a molar ratio of 2 to 5.
Lam taught DPPG and DPPC [claim 10] at molar percentages (mol %) of from about 0% to about 10%, from about 10% to about 30%, from about 30% to about 50%, from about 50% to about 70%, from about 70% to about 90%, or from about 90% to 100%. Peking University taught DHPC.
A prima facie case of obviousness exists because of overlap, as discussed above.
Claim(s) 28-33, 44 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Lam et al (US 2013/0164369A1), in view of Chen et al (US 2021/0338659A1).
The 35 U.S.C. 103 rejection over Lam et al was previously discussed.
Additionally, Lam generally taught therapeutics against infectious agents [0016].
Lam, though, did not specifically teach anti-retroviral therapy, as recited in claims 28-29; a pharmaceutical carrier, as recited in claim 44; administering to a subject, as recited in claim 46.
Chen taught compositions and methods for targeting a viral infection [title]. Therapeutics currently used to treat or prevent viral infections included but were not limited to tenofovir and saquinavir [0328]. Efavirenez was taught in Table 1, but was not required. The therapeutics were formulated in pharmaceutically acceptable carriers [0278], in effective amounts [0310], for administration to subjects in need thereof [0051].
Since Lam generally taught therapeutics against infectious agents, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Lam, anti-retroviral therapeutics, at effective amounts, and administered to subjects in pharmaceutically acceptable carriers, as taught by Chen. In the instant case, it is prima facie obvious to select anti-retroviral therapeutics for incorporation into a composition, based on their recognized suitability for the intended use for targeting and treating viral infections, as taught by Chen et al [0328].
Claims 39 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Lam et al (US 2013/0164369A1), in view of Alper et al (US 2014/0271477 A1).
The 35 U.S.C. 103 rejection over Lam was previously described.
Lam taught nanodiscs comprising an outer surface comprising a targeting ligand, wherein the targeting ligand was generally drawn to an antibody, as previously discussed.
Lam, though, was not specific a targeting antibody that allowed delivery across the blood brain barrier, as recited in claim 39; an anti-EGFR monoclonal antibody, as recited in claim 42.
Alper taught monoclonal anti-EGFR antibodies, wherein the antibodies were useful in diagnostic and therapeutic indications [abstract]. In some embodiments, the anti-EGFR antibody was conjugated to a lipid-based particle [0099].
Since Lam generally taught antibodies, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Lam, monoclonal anti-EGFR antibodies, as taught by Alper. The ordinarily skilled artisan would have been motivated to include antibodies useful in diagnostic and therapeutic indications, as taught by Alper at the abstract. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, it is prima facie obvious to select anti-EGFR antibodies for incorporation into a composition, based on its recognized suitability for its intended use as monoclonal antibodies, as taught by Alper et al.
The instant claim 39 recites that the targeting antibody allows delivery across the blood brain barrier.
The instant Specification, at [0013] disclosed that anti-EGFR monoclonal antibody allows delivery across the blood brain barrier. Therefore, it appears that the compositions of the instant claims (nanodiscs comprising conjugated targeting antibodies, wherein the targeting antibodies comprised anti-EGFR) and those of the combined teachings of the prior art (nanodiscs conjugated to anti-EGFR antibodies) would reasonably be expected to have substantially the same physical and chemical properties (e.g., ability to cross the blood-brain-barrier).
Inherent features need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. MPEP 2112 II. It should be noted that a chemical composition and its properties are inseparable. If the prior art teaches the identical chemical compounds, then the properties that the Applicant discloses and/or claims are necessarily present.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612