DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/15/2026 has been entered.
Previous Rejections
Applicant’s arguments, filed 06/15/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 103 - Obviousness
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, 9-11, 13-15, 17, 35-36, 54, 56-58 are rejected under 35 U.S.C. 103 as being unpatentable over Lam et al (US 2013/0164369 A1), in view of Ma et al (US 2020/0397926 A1).
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 [0080-0082, 0099]. The nanodiscs comprised any suitable combination of lipids (e.g., reads on a mixture), including DPPC (e.g., reads on long-chain phospholipid) [¶ 0079].
Lam did not teach a zwitterionic short-chain phospholipid, as recited in claim 1.
Ma taught nano disks formed of DHPC [examples 4, 6 and 7].
Since Lam taught nanodiscs comprised of suitable lipids, 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 Ma. The ordinarily skilled artisan would have been motivated to form the nanodisc, as taught by Ma at examples 4, 6 and 7.
Lam, in view of Ma, reads on claims 1, 7, 9 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 0.5.
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 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%. Ma taught DHPC.
A prima facie case of obviousness exists because of overlap, as discussed above.
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 about 25 nm to about 900 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.
Claim 56 is rendered prima facie obvious because Lam Amphotericin B (e.g., reads on hydrophobic) [0029].
Claim 57 is rendered prima facie obvious because Lam did not require a cationic lipid.
Claim 58 is rendered prima facie obvious because Lam taught that “forming a reaction mixture” includes assembly into lipid nanodiscs by dissolution or suspension of components in a suitable solvent(s). Forming the reaction mixture also included forming a dried lipid-containing film and swelling or dispersing the film in a suitable solvent or mixture of solvents [0030].
The instant Specification, at [0061], disclosed that “spontaneously formed” includes wherein the formation of the liposome requires the application of minimal or no mechanical force.
It appears that the compositions of the instant claims (nanodiscs formed with minimal or no mechanical force) and those of the combined teachings of the prior art (nanodiscs formed by assembly of components; e.g., dissolution or suspension in solvent, or by dried film swelled or dispersed in solvent) would reasonably be expected to have substantially the same physical and chemical properties (e.g., spontaneous formation of the nanodisc). See MPEP 2112 II.
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(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 Ma et al (US 2020/0397926 A1) and further in view of Chen et al (US 2021/0338659A1).
The 35 U.S.C. 103 rejection over Lam et al and Ma 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].
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.
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 Ma et al (US 2020/0397926 A1) and further in view of Alper et al (US 2014/0271477 A1).
The 35 U.S.C. 103 rejection over Lam and Ma 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 was neuron-specific, 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 was neuron-specific.
The instant Specification, at [0013] disclosed that anti-EGFR monoclonal antibody was neuron-specific. 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., neuron-specific).
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.
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(s) 1, 7, 9-11, 13-15, 17, 35-36 and 54-58 are rejected under 35 U.S.C. 103 as being unpatentable over Bahal et al (US 2021/0369632 A1).
Bahal taught self-assembled nanodiscs [0010] comprised of DHPC, DPPG and DSPE-PEG2000 [claim 2], wherein the discs were coated with antibodies (e.g., reads on conjugated to an antibody) [0022]. Bahal was drawn to the delivery of encapsulated PNA (peptide nucleic acids) [abstract, claim 1, ¶ 0003].
Claim 1 is rendered prima facie obvious over the teachings of Bahal, 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., Bahal) 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.
Bahal reads on claims 1, 7, 9-11, 13, 54-55 and 58.
Claims 14-15 are rendered prima facie obvious because Bahal taught the molar ratio of the zwitterionic long chain diacyl lipid and the charged long chain diacyl lipid to the short chain diacyl lipid at 0.5 to 5 [0023].
The instant claim 14 recites a mole to mole ratio of 0.01 to 0.5.
The instant claim 15 recites a mole to mole ratio of 2 to 5.
Bahal taught a mole to mole ratio of from about 0.5 % to about 5 %. 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 Bahal taught a diameter from about 30 nm and a thickness of about 5 nm [0020].
The instant claim 17 recites a diameter of 30-40 nm and a thickness of about 5 nm.
Bahal taught a diameter of 30 nm and a thickness of 5 nm. A prima facie case of obviousness exists because of overlap, as discussed above.
Claims 35-36 are rendered prima facie obvious because Bahal taught a drug (PNA) to total lipid ratio of 1:500 to 1:2500 [see claim 8].
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.
Bahal taught a therapeutic agent to lipid ratio of 1:500 to 1:2500. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 56 is rendered prima facie obvious because Bahal taught hydrophobic drugs [0020].
Claim 57 is rendered prima facie obvious because Bahal did not teach as required a cationic lipid.
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(s) 28-33, 44 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Bahal et al (US 2021/0369632 A1), in view of Chen et al (US 2021/0338659A1).
The 35 U.S.C. 103 rejection over Bahal et al was previously discussed.
Additionally, Bahal generally taught therapeutics against infectious agents [0070].
Bahal, 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].
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.
Claims 39 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Bahal et al (US 2021/0369632 A1), in view of Alper et al (US 2014/0271477 A1).
The 35 U.S.C. 103 rejection over Bahal was previously described.
Bahal taught nanodiscs comprising an outer surface comprising a targeting ligand, wherein the targeting ligand was generally drawn to an antibody, as previously discussed.
Bahal, though, was not specific a targeting antibody that was neuron-specific, 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 Bahal generally taught antibodies, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Bahal, 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 was neuron-specific.
The instant Specification, at [0013] disclosed that anti-EGFR monoclonal antibody was neuron-specific.
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., neuron-specific).
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
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/CELESTE A RONEY/ Primary Examiner, Art Unit 1612
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