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 and Claim Status
Applicant’s election without traverse of Group 1 in the reply filed on 12/1/25 is acknowledged.
Claims 31-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/1/25.
Applicant’s election of the species of SEQ ID NO:5 (peptide), sphingomyelin and phosphatidylcholine (lipids) and A-R-L-X (A is paclitaxel, R is hydroxyl, L is carbonic acid and X is δ-tocotrienol for the cargo) in the reply filed on 12/1/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Since SEQ ID NO:5 was elected, claims 3-7 and 29-30 are drawn to non-elected species. Since a cargo of A-R-L-X (A is paclitaxel, R is hydroxyl, L is carbonic acid and X is δ-tocotrienol) was elected, claims 22 and 27-28 are drawn to non-elected species. Claim 11 (a specific type of phosphatidylcholine) has been included in the instant examination.
Claims 3-7, 22 and 27-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/1/25.
Claims 1-2, 8-21 and 23-26 are being examined.
Priority
The priority information is found in the filing receipt of 5/19/23.
Claim Rejections - 35 USC § 112
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 1-2, 8-21 and 23-26 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.
Claim 1 line 5 recites ‘group consisting of Aib, Amv, Aml, Amp, Amt;’. The last 2 options of the group are not separated by the word ‘and’ or the word ‘or’. As such, it is unclear if additional residues are possible. Stated another way, something is missing from the claim and it is unclear if one word or more than one word is missing from the claim. None of the dependent claims clarify the claim scope. Although unclear, ‘group consisting of Aib, Amv, Aml, Amp, Amt;’ has been interpreted as a closed group.
Claim 16 recites ‘has a mean particle diameter is from’. Such language is confusing. It is unclear if words are missing from the claim or if unnecessary words are included in the claim. The use of both ‘has’ and ‘is’ makes it unclear if multiple limitations are required or if only a mean particle diameter from about 7.5 nm to about 20 nm is required. Although unclear, claim 16 has been interpreted such that the PALM has a mean particle diameter from about 7.5 nm to about 20 nm’.
Claim 19 recites ‘and δ-tocotrienol, cholecalciferol, or ergocalciferol’. The use of both ‘and’ and ‘or’ within the same group of alternatives makes the scope of the claim unclear. It is unclear if combinations of the alternatives are required (compare the word ‘and’) or if only one of the alternatives is required. None of dependent claims 20-21 clarify the claim scope. Claim 19 has been interpreted as requiring one of the alternatives.
The 2nd and third line of claim 26 include boxes. It would seem that the box is some type of character. However, claim 19 shows that different characters are possible. Although unclear, claim 26 has been interpreted as encompassing the elected cargo compound (which contains δ-tocotrienol).
Although unclear, the claims have been given the 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(s) 1-2, 8-21 and 23-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Homan et al. (WO 2017/011312; first cited 10/2/25; ‘Homan’).
Homan teach a peptide of SEQ ID NO:35 (claims 4 and 39). Homan recites the sequence of SEQ ID NO:35 as DVFQKL{ AIB} ELFNQL{ AIB} EKWKQV (Table 2 page 11). Homan teach that the peptides were amidated at the C-terminus (section 00127 page 30). Homan teach a peptide amphiphile lipid micelle (claims 10-14). Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36 and figure 9). Homan teach that the PALM preparations include sphingomyelin (SM) and DOPC or POPC (example 4 sections 00135-00136 and Table 5). Homan teach various molar ratios and amounts (claims 15-20). Homan teach a PALM-cargo composition (claims 21-36) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). Homan teach a mean particle diameter of from about 7.5 nm to about 20 nm (section 0088). Homan teach an example in which the diameters of the molecules were determined (figure 3).
In relation to claims 1-2, Homan teach a peptide of SEQ ID NO:35 (claims 4 and 39). Homan recites the sequence of SEQ ID NO:35 as DVFQKL{ AIB} ELFNQL{ AIB} EKWKQV (Table 2 page 11). Homan teach that the peptides were amidated at the C-terminus (section 00127 page 30). SEQ ID NO:35 is instant SEQ ID NO:5 (the elected species).
In relation to claims 8-11, Homan teach a peptide amphiphile lipid micelle (claims 10-14). Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36). Homan teach that the PALM preparations include sphingomyelin (SM) and DOPC or POPC (example 4 sections 00135-00136 and Table 5).
In relation to claims 12-15, Homan teach such limitations (claims 17-20).
In relation to claim 16, Homan teach a mean particle diameter of from about 7.5 nm to about 20 nm (section 0088). Homan teach an example in which the diameters of the molecules were determined (figure 3).
In relation to claims 17-21 and 23-26, Homan teach a PALM-cargo composition (claims 21-36) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). The structure shown in section 00133 of Homan is the same as that in section 00100 of the instant specification.
Claim Rejections - 35 USC § 103
This rejection addresses additional embodiments of the claims.
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) 1-2, 8-21 and 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Homan et al. (WO 2017/011312; first cited 10/2/25; ‘Homan’).
Homan teach a peptide of SEQ ID NO:35 (claims 4 and 39). Homan recites the sequence of SEQ ID NO:35 as DVFQKL{ AIB} ELFNQL{ AIB} EKWKQV (Table 2 page 11). Homan teach that the peptides were amidated at the C-terminus (section 00127 page 30). Homan teach a peptide amphiphile lipid micelle (claims 10-14). Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36 and figure 9). Homan teach that the PALM preparations include sphingomyelin (SM) and DOPC or POPC (example 4 sections 00135-00136 and Table 5). Homan teach various molar ratios and amounts (claims 15-20). Homan teach a PALM-cargo composition (claims 21-36) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). Homan teach a mean particle diameter of from about 7.5 nm to about 20 nm (section 0088). Homan teach an example in which the diameters of the molecules were determined (figure 3).
Homan does not provide a working example in which the mean particle diameter of SEQ ID NO:35 was assessed.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Homan based on the specific teachings and suggestions of Homan. Homan teach peptides including SEQ ID NO:35 (claim 4, Table 6 on page 36 and figure 9) and teach peptide amphiphilic lipid micelles and cargo compositions thereof (claims 10-36) as well as specific uses (claims 37-39). Thus, one would have been motivated to make such compositions based on the specific teachings and suggestions. Further, Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36 and figure 9) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). Since Homan provide specific components, amounts, sizes and ratios (claims 13-20 and section 0088) one would have been motivated to make with such components, amounts, sizes and ratios. One would have had a reasonable expectation of success since Homan teach that methods of making and preparing were known (examples 1 and 3-4).
In relation to claims 1-2, Homan teach a peptide of SEQ ID NO:35 (claims 4 and 39). Homan recites the sequence of SEQ ID NO:35 as DVFQKL{ AIB} ELFNQL{ AIB} EKWKQV (Table 2 page 11). Homan teach that the peptides were amidated at the C-terminus (section 00127 page 30). SEQ ID NO:35 is instant SEQ ID NO:5 (the elected species).
In relation to claims 8-11, Homan teach a peptide amphiphile lipid micelle (claims 10-14). Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36). Homan teach that the PALM preparations include sphingomyelin (SM) and DOPC or POPC (example 4 sections 00135-00136 and Table 5).
In relation to claims 12-15, Homan teach such limitations (claims 17-20).
In relation to claim 16, Homan teach a mean particle diameter of from about 7.5 nm to about 20 nm (section 0088). Homan teach an example in which the diameters of the molecules were determined (figure 3).
In relation to claims 17-21 and 23-26, Homan teach a PALM-cargo composition (claims 21-36) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). The structure shown in section 00133 of Homan is the same as that in section 00100 of the instant specification.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 8-10, 17-21 and 23-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,532,105 (105). Although the claims at issue are not identical, they are not patentably distinct from each other.
105 recites SEQ ID NO:35 (claims 2 and 21). 105 recites PALM compositions comprising sphingomyelin and phosphatidylcholine (claims 3-4). 105 recites cargo compositions of formula A-R-L-X where A is paclitaxel and X is δ-tocotrienol and RI is a hydroxyl group and the anchor moiety is bonded by a carbonate ester bond (claims 8-19).
In relation to claims 1-2, 105 recites SEQ ID NO:35 (claims 2 and 21) which is instant SEQ ID NO:5 (the elected species).
In relation to claims 8-10, 105 recites PALM compositions comprising sphingomyelin and phosphatidylcholine (claims 3-4).
In relation to claims 17-21 and 23-26, 105 recites cargo compositions of formula A-R-L-X where A is paclitaxel and X is δ-tocotrienol and RI is a hydroxyl group and the anchor moiety is bonded by a carbonate ester bond (claims 8-19).
Claims 1-2, 8-21 and 23-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,532,105 (105) in view of Homan et al. (WO 2017/011312; first cited 10/2/25; ‘Homan’).
105 recites SEQ ID NO:35 (claims 2 and 21). 105 recites PALM compositions comprising sphingomyelin and phosphatidylcholine (claims 3-4). 105 recites cargo compositions of formula A-R-L-X where A is paclitaxel and X is δ-tocotrienol and RI is a hydroxyl group and the anchor moiety is bonded by a carbonate ester bond (claims 8-19).
105 does not recite all of the ratios of the instant claims.
Homan teach a peptide of SEQ ID NO:35 (claims 4 and 39). Homan recites the sequence of SEQ ID NO:35 as DVFQKL{ AIB} ELFNQL{ AIB} EKWKQV (Table 2 page 11). Homan teach that the peptides were amidated at the C-terminus (section 00127 page 30). Homan teach a peptide amphiphile lipid micelle (claims 10-14). Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36 and figure 9). Homan teach that the PALM preparations include sphingomyelin (SM) and DOPC or POPC (example 4 sections 00135-00136 and Table 5). Homan teach various molar ratios and amounts (claims 15-20). Homan teach a PALM-cargo composition (claims 21-36) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). Homan teach a mean particle diameter of from about 7.5 nm to about 20 nm (section 0088). Homan teach an example in which the diameters of the molecules were determined (figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 105 because Homan teach the same peptide (SEQ ID NO:35 of claim 4, Table 6 on page 36 and figure 9) and teach peptide amphiphilic lipid micelles and cargo compositions thereof (claims 10-36) as well as specific uses (claims 37-39). Thus, one would have been motivated to make such compositions based on the specific teachings and suggestions. Further, Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36 and figure 9) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). Since Homan provide specific components, amounts, sizes and ratios (claims 13-20 and section 0088) one would have been motivated to make with such components, amounts, sizes and ratios. One would have had a reasonable expectation of success since Homan teach that methods of making and preparing were known (examples 1 and 3-4).
In relation to claims 1-2, Homan teach a peptide of SEQ ID NO:35 (claims 4 and 39). Homan recites the sequence of SEQ ID NO:35 as DVFQKL{ AIB} ELFNQL{ AIB} EKWKQV (Table 2 page 11). Homan teach that the peptides were amidated at the C-terminus (section 00127 page 30). SEQ ID NO:35 is instant SEQ ID NO:5 (the elected species).
In relation to claims 8-11, Homan teach a peptide amphiphile lipid micelle (claims 10-14). Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36). Homan teach that the PALM preparations include sphingomyelin (SM) and DOPC or POPC (example 4 sections 00135-00136 and Table 5).
In relation to claims 12-15, Homan teach such limitations (claims 17-20).
In relation to claim 16, Homan teach a mean particle diameter of from about 7.5 nm to about 20 nm (section 0088). Homan teach an example in which the diameters of the molecules were determined (figure 3).
In relation to claims 17-21 and 23-26, Homan teach a PALM-cargo composition (claims 21-36) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). The structure shown in section 00133 of Homan is the same as that in section 00100 of the instant specification.
Claims 1-2, 8-11, 17-21 and 23-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-66 of copending Application No. 17/634,975 (reference application; ‘975’). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
975 teach the peptide of SEQ ID NO:35 (claim 55). 975 teach sphingomyelin and 1-palmitoyl-2-oleoyl-phophatidylcholine (POPC) (claim 55). 975 teach conjugates (claim 55).
In relation to claims 1-2, 975 teach the peptide of SEQ ID NO:35 (claim 55) which is instant SEQ ID NO:5 (the elected species).
In relation to claims 8-11, 975 teach sphingomyelin and 1-palmitoyl-2-oleoyl-phophatidylcholine (POPC) (claim 55).
In relation to claims 17-21 and 23-26, 975 teach conjugates (claim 55).
Claims 1-2, 8-21 and 23-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-66 of copending Application No. 17/634,975 (reference application; ‘975’) in view of Homan et al. (WO 2017/011312; first cited 10/2/25; ‘Homan’).
This is a provisional nonstatutory double patenting rejection.
975 teach the peptide of SEQ ID NO:35 (claim 55). 975 teach sphingomyelin and 1-palmitoyl-2-oleoyl-phophatidylcholine (POPC) (claim 55). 975 teach conjugates (claim 55).
975 does not recite all of the ratios of the instant claims.
Homan teach a peptide of SEQ ID NO:35 (claims 4 and 39). Homan recites the sequence of SEQ ID NO:35 as DVFQKL{ AIB} ELFNQL{ AIB} EKWKQV (Table 2 page 11). Homan teach that the peptides were amidated at the C-terminus (section 00127 page 30). Homan teach a peptide amphiphile lipid micelle (claims 10-14). Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36 and figure 9). Homan teach that the PALM preparations include sphingomyelin (SM) and DOPC or POPC (example 4 sections 00135-00136 and Table 5). Homan teach various molar ratios and amounts (claims 15-20). Homan teach a PALM-cargo composition (claims 21-36) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). Homan teach a mean particle diameter of from about 7.5 nm to about 20 nm (section 0088). Homan teach an example in which the diameters of the molecules were determined (figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 975 because Homan teach the same peptide (SEQ ID NO:35 of claim 4, Table 6 on page 36 and figure 9) and teach peptide amphiphilic lipid micelles and cargo compositions thereof (claims 10-36) as well as specific uses (claims 37-39). Thus, one would have been motivated to make such compositions based on the specific teachings and suggestions. Further, Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36 and figure 9) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). Since Homan provide specific components, amounts, sizes and ratios (claims 13-20 and section 0088) one would have been motivated to make with such components, amounts, sizes and ratios. One would have had a reasonable expectation of success since Homan teach that methods of making and preparing were known (examples 1 and 3-4).
In relation to claims 1-2, Homan teach a peptide of SEQ ID NO:35 (claims 4 and 39). Homan recites the sequence of SEQ ID NO:35 as DVFQKL{ AIB} ELFNQL{ AIB} EKWKQV (Table 2 page 11). Homan teach that the peptides were amidated at the C-terminus (section 00127 page 30). SEQ ID NO:35 is instant SEQ ID NO:5 (the elected species).
In relation to claims 8-11, Homan teach a peptide amphiphile lipid micelle (claims 10-14). Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36). Homan teach that the PALM preparations include sphingomyelin (SM) and DOPC or POPC (example 4 sections 00135-00136 and Table 5).
In relation to claims 12-15, Homan teach such limitations (claims 17-20).
In relation to claim 16, Homan teach a mean particle diameter of from about 7.5 nm to about 20 nm (section 0088). Homan teach an example in which the diameters of the molecules were determined (figure 3).
In relation to claims 17-21 and 23-26, Homan teach a PALM-cargo composition (claims 21-36) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). The structure shown in section 00133 of Homan is the same as that in section 00100 of the instant specification.
Claims 1-2. 8-11, 16-21 and 23-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of copending Application No. 19/204,092 (reference application; ‘092’). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
092 recites SEQ ID NO:35 (claims 2ci and 9a and 17a and 21). 092 recites sphingomyelin and phosphatidylcholine (claims 2cii and 9b and 17b) and specifically recites 1-palmitoyl-2-oleoyl-phosphatidylcholine (claim 24biv). 092 recites a conjugate (claims 2cii and 9c and 17c see specifically compound 78 on page 17). 092 recites an average particle diameter of from about 11.5 nm to about 14 nm (claim 1).
In relation to claims 1-2, 092 recites SEQ ID NO:35 (claims 2ci and 9a and 17a and 21) which is instant SEQ ID NO:5 (the elected species).
In relation to claims 8-11, 092 recites sphingomyelin and phosphatidylcholine (claims 2cii and 9b and 17b) and specifically recites 1-palmitoyl-2-oleoyl-phosphatidylcholine (claim 24).
In relation to claim 16, 092 recites an average particle diameter of from about 11.5 nm to about 14 nm (claim 1).
In relation to claims 17-21 and 23-26, 092 recites a conjugate (claims 2cii and 9c and 17c see specifically compound 78 on page 17).
Claims 1-2, 8-21 and 23-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of copending Application No. 19/204,092 (reference application; ‘092’) in view of Homan et al. (WO 2017/011312; first cited 10/2/25; ‘Homan’).
This is a provisional nonstatutory double patenting rejection.
092 recites SEQ ID NO:35 (claims 2ci and 9a and 17a and 21). 092 recites sphingomyelin and phosphatidylcholine (claims 2cii and 9b and 17b) and specifically recites 1-palmitoyl-2-oleoyl-phosphatidylcholine (claim 24). 092 recites a conjugate (claims 2cii and 9c and 17c see specifically compound 78 on page 17). 092 recites an average particle diameter of from about 11.5 nm to about 14 nm (claim 1).
092 does not recite all of the ratios of the instant claims.
Homan teach a peptide of SEQ ID NO:35 (claims 4 and 39). Homan recites the sequence of SEQ ID NO:35 as DVFQKL{ AIB} ELFNQL{ AIB} EKWKQV (Table 2 page 11). Homan teach that the peptides were amidated at the C-terminus (section 00127 page 30). Homan teach a peptide amphiphile lipid micelle (claims 10-14). Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36 and figure 9). Homan teach that the PALM preparations include sphingomyelin (SM) and DOPC or POPC (example 4 sections 00135-00136 and Table 5). Homan teach various molar ratios and amounts (claims 15-20). Homan teach a PALM-cargo composition (claims 21-36) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). Homan teach a mean particle diameter of from about 7.5 nm to about 20 nm (section 0088). Homan teach an example in which the diameters of the molecules were determined (figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 092 because Homan teach the same peptide (SEQ ID NO:35 of claim 4, Table 6 on page 36 and figure 9) and teach peptide amphiphilic lipid micelles and cargo compositions thereof (claims 10-36) as well as specific uses (claims 37-39). Thus, one would have been motivated to make such compositions based on the specific teachings and suggestions. Further, Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36 and figure 9) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). Since Homan provide specific components, amounts, sizes and ratios (claims 13-20 and section 0088) one would have been motivated to make with such components, amounts, sizes and ratios. One would have had a reasonable expectation of success since Homan teach that methods of making and preparing were known (examples 1 and 3-4).
In relation to claims 1-2, Homan teach a peptide of SEQ ID NO:35 (claims 4 and 39). Homan recites the sequence of SEQ ID NO:35 as DVFQKL{ AIB} ELFNQL{ AIB} EKWKQV (Table 2 page 11). Homan teach that the peptides were amidated at the C-terminus (section 00127 page 30). SEQ ID NO:35 is instant SEQ ID NO:5 (the elected species).
In relation to claims 8-11, Homan teach a peptide amphiphile lipid micelle (claims 10-14). Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36). Homan teach that the PALM preparations include sphingomyelin (SM) and DOPC or POPC (example 4 sections 00135-00136 and Table 5).
In relation to claims 12-15, Homan teach such limitations (claims 17-20).
In relation to claim 16, Homan teach a mean particle diameter of from about 7.5 nm to about 20 nm (section 0088). Homan teach an example in which the diameters of the molecules were determined (figure 3).
In relation to claims 17-21 and 23-26, Homan teach a PALM-cargo composition (claims 21-36) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). The structure shown in section 00133 of Homan is the same as that in section 00100 of the instant specification.
Claims 1-2, 8-10, 17-21 and 23-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 19/204,171 (reference application; ‘171’). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
171 teach SEQ ID NO:35 (claim 2 and 9a and 19). 171 teach sphingomyelin and phosphatidylcholine (claim 1ii and 9b) and a conjugate (claim 1iii and 9c). 171 teach an particle diameter of about 12 nm to about 13.5 nm (claim 3). 171 teach conjugates of table 6 (claim 15, see compound 78 on page 19 of the specification).
In relation to claims 1-2, 171 teach SEQ ID NO:35 (claim 2 and 9a and 19). which is instant SEQ ID NO:5 (the elected species).
In relation to claims 8-10, 171 teach sphingomyelin and phosphatidylcholine (claim 1ii and 9b).
In relation to claims 17-21 and 23-26, 171 teach conjugates of table 6 (claim 15, see compound 78 on page 19 of the specification).
Claims 1-2, 8-21 and 23-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 19/204,171 (reference application; ‘171’) in view of Homan et al. (WO 2017/011312; first cited 10/2/25; ‘Homan’).
This is a provisional nonstatutory double patenting rejection.
171 teach SEQ ID NO:35 (claim 2 and 9a and 19). 171 teach sphingomyelin and phosphatidylcholine (claim 1ii and 9b) and a conjugate (claim 1iii and 9c). 171 teach an particle diameter of about 12 nm to about 13.5 nm (claim 3). 171 teach conjugates of table 6 (claim 15, see compound 78 on page 19 of the specification).
171 does not recite all of the ratios of the instant claims.
Homan teach a peptide of SEQ ID NO:35 (claims 4 and 39). Homan recites the sequence of SEQ ID NO:35 as DVFQKL{ AIB} ELFNQL{ AIB} EKWKQV (Table 2 page 11). Homan teach that the peptides were amidated at the C-terminus (section 00127 page 30). Homan teach a peptide amphiphile lipid micelle (claims 10-14). Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36 and figure 9). Homan teach that the PALM preparations include sphingomyelin (SM) and DOPC or POPC (example 4 sections 00135-00136 and Table 5). Homan teach various molar ratios and amounts (claims 15-20). Homan teach a PALM-cargo composition (claims 21-36) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). Homan teach a mean particle diameter of from about 7.5 nm to about 20 nm (section 0088). Homan teach an example in which the diameters of the molecules were determined (figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 171 because Homan teach the same peptide (SEQ ID NO:35 of claim 4, Table 6 on page 36 and figure 9) and teach peptide amphiphilic lipid micelles and cargo compositions thereof (claims 10-36) as well as specific uses (claims 37-39). Thus, one would have been motivated to make such compositions based on the specific teachings and suggestions. Further, Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36 and figure 9) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). Since Homan provide specific components, amounts, sizes and ratios (claims 13-20 and section 0088) one would have been motivated to make with such components, amounts, sizes and ratios. One would have had a reasonable expectation of success since Homan teach that methods of making and preparing were known (examples 1 and 3-4).
In relation to claims 1-2, Homan teach a peptide of SEQ ID NO:35 (claims 4 and 39). Homan recites the sequence of SEQ ID NO:35 as DVFQKL{ AIB} ELFNQL{ AIB} EKWKQV (Table 2 page 11). Homan teach that the peptides were amidated at the C-terminus (section 00127 page 30). SEQ ID NO:35 is instant SEQ ID NO:5 (the elected species).
In relation to claims 8-11, Homan teach a peptide amphiphile lipid micelle (claims 10-14). Homan teach that SEQ ID NO:35 was prepared as PALM and assayed (Table 6 on page 36). Homan teach that the PALM preparations include sphingomyelin (SM) and DOPC or POPC (example 4 sections 00135-00136 and Table 5).
In relation to claims 12-15, Homan teach such limitations (claims 17-20).
In relation to claim 16, Homan teach a mean particle diameter of from about 7.5 nm to about 20 nm (section 0088). Homan teach an example in which the diameters of the molecules were determined (figure 3).
In relation to claims 17-21 and 23-26, Homan teach a PALM-cargo composition (claims 21-36) and specifically teach that XT3 is paclitaxel 2’- δ-tocotrienol carbonate (sections 0036, 00130-00134 and 00143-00144). The structure shown in section 00133 of Homan is the same as that in section 00100 of the instant specification.
Conclusion
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658