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
In response to the restriction requirement dated 28 May, 2026, Applicant elects, without
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traverse: Group I encompassing claims 1-7, 9, 11, 13, 15-16, 20-21, 28-29, 33, 72, 73 and 112; and species of nanoparticle ‘A’ within the conjugate having the structure of formula (I) is an apolipoprotein mimetic comprising an amino acid sequence having at least about 70 % sequence identity to the amino acid sequence of SEQ ID NO: 1 and ‘R’ is , payload is AD198 and lipid is DHPC.
Applicant's election in the reply filed on 22 July 2026 is acknowledged.
Claims 1-7, 9, 11, 13, 15-16, 20-21, 28-29, 33, 72, 73 and 112, are hereby examined on the merits. Claim 110 is withdrawn from further consideration pursuant to 37 CFR l.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Priority
This application filed 01/17/2024 Claims Priority from Provisional Application 63480269 , filed 01/17/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/12/2024 and 01/17/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9, 11, 13, 16, 72, 73 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Andras G. Lacko et al., hereinafter Lacko (Andras G. Lacko et al., US2015/0343069A1, EFD May 29, 2015).
Regarding claim 1, Lacko teaches drug delivery vehicle comprising SEQ ID NO: 20-myr (i.e. peptide ‘A’, myr=myristoyl peptide i.e. ‘R’) and encapsulated paclitaxel (i.e. payload) (see Fig 8 [0020]). Note that SEQ ID NO:20 (page 21) is 100 % identical to the elected SEQ ID NO: 1 in instant.
Regarding claim 2, Lacko teaches that the drug delivery vehicle has a size range of 20 nm to 100 nm in diameter ([0073] line 7). See Fig 2 scale bar.
Regarding claim 3, Lacko teaches final myristoyl-5A peptide concentration is 0.5 mg/ml in 2 ml PBS (i.e. conjugate) ([0147]). Lacko teaches that paclitaxel (i.e. payload) solubility ranges from 2.11-119 µg/ml ([0154] lines 8-10), generating a ratio of payload:conjugate in the range of 1:4 to 1:250. Additionally, Lacko teaches that drug Paclitaxel (2 mg/ml) is added to Myristoyl 5A peptide solution that is 10 mg/ml, generating a ratio of 1:5 ([0101], lines 3-5).
Regarding claim 4, Lacko teaches myristoyl peptide as noted above, i.e. C6-40 alkyl.
Regarding claim 5, Lacko teaches myristoyl peptide as noted above, i.e. CH3(CH2)12CO-
Regarding claim 6, Lacko teaches myristoyl peptide i.e. CH3(CH2)12CO- noted above.
Regarding claim 7, Lacko teaches apolipoprotein. See Fig 6A comparing % payload recovery by ApoA1-Valrubicin in column 1 (sheet 6).
Regarding claim 9, Lacko teaches apolipoprotein mimetic (see Example 8, [0159]).
Regarding claim 11, Lacko teaches SEQ ID NO: 20 (see page 21) i.e. 100 % identity to SEQ ID NO: 1 in instant.
Regarding claim 13, Lacko teaches therapeutic agent e.g. valrubicin in Example 1 (page 16) i.e. therapeutic agent.
Regarding claim 16, Lacko teaches Valrubicin in Example 1, page 16 (i.e. alkaloid).
Regarding claim 72, Lacko teaches PBS buffer i.e. excipient [0147].
Regarding claim 73, Lacko teaches peptide purity greater than 98 % (i.e. less than about 5% impurities). See [0146], line 6.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-7, 9, 11, 13, 15, 16, 20, 21, 28, 29, 33, 72 and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Andras G. Lacko et al., hereinafter Lacko (Andras G. Lacko et al., US2015/0343069A1, EFD May 29, 2015).
The teachings in Lacko have been set forth above.
Additionally, regarding claim 15, Lacko teaches anthracyclines (see page 12, [0117]), bleomycin [0123], mitomycin [0123], chemotherapeutic drugs envisioned to be administered by the drug delivery vehicle to a patient suffering from a hyperproliferative disease [0117].
Lacko does not teach the recited therapeutic agents in a single embodiment.
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery vehicle comprising therapeutic agent, and introduce an alternate therapeutic agent recited in the claim, as specifically disclosed in Lacko. One motivated to do so would have a reasonable expectation of success as Lacko specifically teaches drug delivery vehicle compositions. Thus, one would have recognized that applying the teachings of Lacko and modifying the teachings with suggested therapeutic agents, would have yielded predictable results and improved the therapeutic utility of the composition (See MPEP § 2143 l(A)(D)).
Regarding claim 20, the obviousness rational has been set forth above. Additionally, Lacko teaches daunorubicin ([0123, line 6), bleomycin ([0123] line 4), mitomycin ([0123] line 4), cyclophosphamide ([0124], line 24), epirubicin [0123], etc.
Regarding claim 21, Lacko teaches rapamycin [0084].
Regarding claim 28, Lacko teaches drug delivery vehicle comprising phospholipid ([0086] line 7).
Regarding claim 29, Lacko teaches phospholipid ([0086] line 7) and myristoyl-5A peptide [0147], i.e. lipopeptide.
Regarding claim 33, Lacko teaches drug delivery vehicle comprising palmitoyl-oleys phosphatidylcholine (see claim 78).
Lacko does not teach palmitoylated peptide in a single embodiment.
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery vehicle comprising myristoylated peptide, and introduce a palmitoylated peptide recited in the claim, as specifically disclosed in Lacko. One motivated to do so would have a reasonable expectation of success as Lacko specifically teaches that suitable aliphatic chains to be used with the amino-acid composition include fatty acids, glycerolipids, glycerophospholipids, shhingolipids, sterol lipids, etc ([0061] lines 14-17). Thus, one would have recognized that applying the teachings of Lacko and modifying the teachings with suggested fatty acids, such as palmitic acid, would have yielded predictable results and improved the therapeutic utility of the composition (See MPEP § 2143 l(A)(D)).
Claim(s) 1-7, 9, 11, 13, 15, 16, 20, 21, 28, 29, 33, 72, 73 and 112 are rejected under 35 U.S.C. 103 as being unpatentable over Andras G. Lacko et al., hereinafter Lacko (Andras G. Lacko et al., US2015/0343069A1, EFD May 29, 2015) in view of Kathryn Crouch et al., hereinafter Crouch (Kathryn Crouch et al., June 15, 2022 Cancer Res (2022) 82 (12_Supplement): Poster presentation Abstract #375) further in view of Melissa Stenner, hereinafter Stenner (Thesis Title: Temperature-sensitive liposomes as a unique model for controlled drug delivery, April 1998).
The teachings of Lacko have been set forth above.
Additionally, regarding claim 112, Crouch teaches self-assembling micelle structure composed of myristic acid conjugated to an Apo-A1 mimetic 5A peptide, termed Myr5A nanoparticles (i.e. elected ‘A’ and elected ‘R’). Cronch teaches AD198 in the nanoparticle (i.e. elected payload) to favor micelle stability.
Cronch and Lacko do not teach DHPC.
Stenner teaches that DHPC liposomes as potential drug delivery vehicles (see Abstract, page ix). Stenner teaches that DHPC is more clinically relevant than the other liposomes since it releases above physiological temperature.
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery vehicle of Lacko and Cronch and introduce DHPC as the phospholipid. One motivated to do so would have a reasonable expectation of success as Lacko specifically teaches phospholipid ([0086] line 7). Thus, one would have recognized that applying the teachings of Lacko and Cronch and modifying the teachings with DHPC, as suggested in Stenner, would have yielded predictable results as Stenner specifically discloses that DHPC offers a temperature-sensitive liposome, that is a unique therapeutic technique for selective drug delivery (see last few lines, page x) (See MPEP § 2143 l(A)(D)).
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARCHANA VARADARAJ/ Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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