-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 .
Applicant’s response dated September 3, 2026 is acknowledged.
Priority
This application claims benefit in provisional application 63/587,040 filed on 09/29/2023.
Claim Status
Claims 29, 40, 42, 52-55, 58, 60, 61, 65, and 70 are pending. Claims 1-28, 30-39, 41, 43-51, 56, 57, 59, 62-64, and 66-69 were cancelled. Claim 29 was amended. Claims 52-55, 58, 60, and 61 are withdrawn. Claims 29, 40, 42, 65, and 70 are examined on the merits.
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.
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 29, 40, 42, 65, and 70 are rejected under 35 U.S.C. 103 as being unpatentable
over Duong (US 2022/0175812 Al Published June 9, 2022 - ofrecord in IDS dated 11/08/2024),
Muppalla (Wiley Periodicals, Inc., 2012, 1637-1650 - ofrecord in PTO-892 dated 08/06/2025),
and Trieu (US 2016/0151498 Al Published June 2, 2016 - of record in PTO-892 dated
08/26/2025).
The claims encompass a polymer nanoparticle comprising a block copolymer, the block
copolymer comprising a first block homopolymers of dimethylaminoethyl methacrylate
(DMAEMA) and a second block comprising a homopolymer of methyl methacrylate (MMA).
The teachings of Duong are related to polymer nanoparticles for delivery of active agent (Abstract). The polymer is formed by RAFT polymerization and has the structure
CTACap-[Block l]m-[Block 2]n-CTACap
where each CTACap is a capping unit derived from the chain transfer agent(s) used in the
process for preparing the RAFT copolymer. The CTA used for preparing each of Block 1 and
Block 2 can be the same or different. In some embodiments, the CTA used to prepare each of
Block 1 and Block 2 is the same (e.g. macroCTA). In some embodiments, the CTA used to
prepare each of Block 1 and Block 2 is different. In some embodiments, the CTA used to prepare
one or both of Block 1 and Block 2 comprises a functional group for the covalent attachment of a
biomolecule, drug, or label to the RAFT copolymer. In some embodiments, the covalent
attachment can be via an ester or an amide bond. In some embodiments, the covalent attachment
can be via EDC-NHS chemistry. In some embodiments, the first capping unit is of the formula
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. In some embodiments, the second capping unit is of the formula A
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where R is -SC2-C12 alkyl or C6H5 (paragraph 0459). In some embodiments, each of Block 1 and Block 2 can comprise one or more monomer units polymerized using a
RAFT polymerization process. It will be appreciated that the identity of the monomer units is not
particularly limited so long as the monomer units being used are compatible with a RAFT
polymerization process. Suitable monomer units include but are not limited to 2-
dimethylaminoethyl acrylate (DMAEMA), 2-(diethylamino) ethyl methacrylate (DEAEMA),
and methyl methacrylate (paragraph 0461). In some embodiments, the first block can be
prepared from one or more monomer units and have a molecular weight (Mn) in the range of
about 20 kDa to about 80 kDa and a degree of polymerization in the range of about 20 to
about 400 (paragraph 0468). In some embodiments, the second block can be prepared from one
or more monomer units, and can have a molecular weight (Mn) in the range of about I kDa to
about 80 kDa and a degree of polymerization in the range of about 3 to about 500 (paragraph
0469). An example of a block copolymer having 100% dimethylaminoethyl methacrylate in
block 1, and a mix of monomers in a block 2 is taught in paragraphs 0526-0528. Table in
paragraph 0538 provides a polymer library which encompasses a block copolymer
poly(DMAEMA)-b-poly(MMA) where DMAEMA means 2-dimethylaminoethyl acrylate and
MMA means methyl methacrylate (paragraph 0461).
Doung and Muppalla do not teach the polydispersity index of the polymer nanoparticle.
The teachings of Trieu are related to nanoparticle drugs for cancer treatment (Abstract).
Nanoparticles include polymer micelles (paragraph 0038). Micelles are monodisperse with a
polydispersity index of approximately 0.13 (paragraph 0049).
The teachings of Trieu and Duong modified with Muppalla are related to drug delivery
vehicles in the form of nanoparticles, and it would have been obvious to have combined their
teachings because they are in the same field of endeavor.
Regarding claims 29, 65, and 70, it would have beenprimafacie obvious to a person of
ordinary skill in the art before the effective filing date of the claimed invention to have formed a
polymer nanoparticle comprising a first block homopolymer of dimethylaminoethyl methacrylate
and a second block homopolymer of methyl methacrylate, with a reasonable expectation of
success because Duong teaches a polymer nanoparticle formed from a block copolymer
comprising a first block and a second block, where Duong exemplifies block copolymers having
a homopolymer of dimethylaminoethyl methacrylate as the first block, and a homopolymer of
methyl methacrylate as the second block. It is noted that in example 3A "Preparation of RAFT
Copolymers" (paragraphs 0510-0534), Duong teaches the acronym DMAEMA to mean 2-
dimethylaminoethyl methacrylate in the Table, however in the description of the method Duong
refers to DMAEMA as dimethylaminoethyl methacrylate, which matches the acronym. In view
of this discrepancy, the reference by Muppalla is relied upon to show that dimethylaminoethyl
methacrylate was known to be suitable for making a block copolymer with methyl methacrylate
where the block copolymer is intended for drug delivery. Therefore, it would have been obvious
to the skilled artisan to have formed Duong's block copolymer having a first block that is
homopolymer of dimethylaminoethyl methacrylate and a second block that is a homopolymer of
methyl methacrylate. It would have been obvious to have formed the nanoparticles in the
nanometer range of 1-1000 nm because the skilled artisan would have recognized that a
nanoparticle would fall in the nanometer range. The claimed particle size ranges of 230-320 nm
and 220-350 nm are obvious because the ranges overlap with 1-1000 nm.
It would have been obvious to have formed the first block having a molecular weight of
20-80 kDa because Duong teaches 20-80 kDa as a suitable molecular weight range of the first
block. The claimed ranges of about 15,000 Da about 45,000 Da, from about 30 kDa to about
45 kDa, and about 20 kDa are obvious because the claimed ranges overlap with 20-80 kDa.
Doung teaches that the polymer is formed by RAFT polymerization and has the structure
CTACap-[Block l]m-[Block 2]n-CTACap, where each CTACap is a capping unit derived from
the chain transfer agent(s) used in the process for preparing the RAFT copolymer. Therefore,
Doung's teachings meet the limitation that requires the first block is coupled to a first cap and
the second block is coupled to a second cap, wherein each of the first cap and the second cap is
derived from a RAFT chain transfer agent.
It would have been obvious to have formed the second block having a degree of
polymerization of 3-500 because Duong teaches 3-500 as a suitable degree of polymerization for
the second block. The claimed range of about 450 to about 575 is obvious because it overlaps
with 3-500.
It would have been prima facie obvious to a person of ordinary skill in the art before the
effective filing date of the claimed invention to have formed the nanoparticles of Duong having a
polydispersity index of about 0.13, with a reasonable expectation of success because it was
known from Trieu that nanoparticles having a polydispersity index of about 0.13 are useful for
drug delivery. The claimed range is obvious because it encompasses about 0.13. Combining prior
art elements according to known methods to obtain predictable results supports obviousness.
Regarding claims 40 and 42, it would have been obvious to have formed the block
copolymer having
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as the endcap of the first block and having
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where R
is -SC2-Cl2 alkyl or C6H5 as the endcap of the second block because Duong teaches said
endcaps on the first block and the second block, respectively.
The specification was reviewed and there is no evidence of criticality of claimed ranges
or of combinations of claimed elements. Therefore, the claimed invention is prima facie obvious
as described above. Combining prior art elements according to known methods to obtain
predictable results supports obviousness.
Double Patenting Rejections
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 29, 40, 42, 65, and 70 are provisionally rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1-41 of copending Application No.
19/353,413 (reference application), and further in view of Doung and Trieu.
Copending claims teach a polymer nanoparticle comprising a block copolymer
comprising a first block and the second block wherein the first block and the second block are
capped with a moiety derived from a RAFT agent, which meet all structural requirements of
instantly claimed block copolymer. Copending claims teach nanoparticle diameter range which
overlaps with the instantly claimed nanoparticle diameter ranges. Copending claims teach first
block molecular weight range that overlaps with instantly claimed molecular weight range of the
first block.
It would have been prima facie obvious to a person of ordinary skill in the art before the
effective filing date of the claimed invention to have formed the nanoparticles in copending
claims having a polydispersity index of about 0.13, with a reasonable expectation of success
because it was known from Trieu that nanoparticles having a polydispersity index of about 0.13
are useful for drug delivery. The claimed range is obvious because it encompasses about 0.13.
It would have been obvious to have formed the block copolymer in view of the teachings
of Doung wherein the second block has a degree of polymerization of 3-500, which renders the
claimed ranges obvious because they overlap with 3-500.
Combining prior art elements according to known methods to obtain predictable results
supports obviousness.
This is a provisional nonstatutory double patenting rejection because the patentably
indistinct claims have not in fact been patented.
Claims 29, 40, 42, 65, and 70 are provisionally rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1-14, 17-19, 38-45 of copending Application
No. 19/291,060 (reference application) and further in view of Doung and Trieu.
Copending claims teach a polymer nanoparticle comprising a block copolymer
comprising a first block and the second block wherein the first block and the second block are
capped with a moiety derived from a RAFT agent, which meet all structural requirements of
instantly claimed block copolymer. Copending claims teach nanoparticle diameter range which
overlaps with the instantly claimed nanoparticle diameter ranges. Copending claims teach first
block molecular weight range that overlaps with instantly claimed molecular weight range of the
first block.
It would have been prima facie obvious to a person of ordinary skill in the art before the
effective filing date of the claimed invention to have formed the nanoparticles in copending
claims having a polydispersity index of about 0.13, with a reasonable expectation of success
because it was known from Trieu that nanoparticles having a polydispersity index of about 0.13
are useful for drug delivery. The claimed range is obvious because it encompasses about 0.13.
It would have been obvious to have modified the block copolymer in view of Doung by
making the second block having a degree of polymerization of 3-500 with a reasonable
expectation of success because it was known from Doung that the second block of the di block
copolymer may be a degree of polymerization in the range of 3-500, which overlaps with the
instantly claimed range.
Combining prior art elements according to known methods to obtain predictable results
supports obviousness.
This is a provisional nonstatutory double patenting rejection because the patentably
indistinct claims have not in fact been patented.
Double patenting rejections are maintained because applicant requested the rejections to
be held in abeyance until agreement on the allowable subject matter of the present application.
Response to Arguments
Applicant's arguments submitted in the remarks dated September 3, 2026 were fully
considered but are not persuasive for the following reasons.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may 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 found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Doung teaches nanoparticles comprising a block copolymer capped at each end with a moiety derived from a RAFT chain transfer agent and specifically poly(DMAEMA)-b-poly(MMA), Doung teaches a particle size range that renders the claimed particle size range obvious, Doung teach a molecular weight range of the first block that renders the claimed molecular weight range of the first block obvious, and degree of polymerization of the second block that renders the claimed range obvious. One of ordinary skill in the art would have had a reasonable expectation of success in making the claimed polymer nanoparticle in view of Doung because the purpose of Doung is to make a polymer nanoparticle using the same polymer as claimed. The polydispersity index of the nanoparticle is not taught by Doung, but it was known from Trieu. All claimed elements are present in the prior art references and all of the claimed ranges overlap with the prior art ranges. The specification was reviewed and there is no evidence of criticality or unexpected results. The decision in In re Stepan was reviewed, but it is not analogous to the instant rejection. The instant rejection is not based on a rationale that it would have been obvious to optimize a combination of claimed elements in order to arrive at a property. The skilled artisan would have arrived at the claimed features because Doung teaches a nanoparticle comprising a block copolymer that meets the claimed limitations, and the claimed ranges are obvious because they overlap with prior art ranges. It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. The rejection does not rely on modifying the prior art ranges to arrive at the claimed ranges. With regards to the block copolymer, the rejection does not rely on modifying Doung's block copolymer to arrive at the claimed copolymer. Doung teaches block copolymers and teaches monomers suitable for making the block copolymer. The claimed block copolymer is obvious because Doung teaches it. The complexity of the claimed invention was taken into consideration, however Doung teaches all of the limitations and ranges that overlap with claimed ranges, with the exception of the nanoparticle PDI which is obvious over Trieu.
The data submitted in the declaration on September 3, 2026 was fully considered but is not sufficient to overcome the rejections based on secondary considerations.
To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
In the instant case, applicant tested two populations of particle sizes encompassed by the claimed range, PNP 1 (average diameter 278 nm) and PNP 5 (average diameter 221 nm); and two populations of particle sizes outside the lower end of the claimed range, Small PNP A (average diameter 20 nm) and Small PNP B (average diameter 21 nm). No comparative tests were done outside the upper end of the claimed range.
The data in Figure 2 has the following issues. It is not clear what the circles, squares, diamonds, and triangles represent. Applicant stated that the transfection results for the PNP 1 and PNP 5 range from 25% to 33%. Based on the graph, the triangles across the two experiments for PNP 1 and PNP 5 range from as low as about 15% (lowest triangle in PNP 1 data cluster) to as high as about 40% (highest triangle in PNP 5 data cluster). The meaning of the triangles is not clear because the % transfection efficiency (position of the triangles) on the graph does not correspond to % transfection efficiency values described by the declarant. The same analysis is applied to Small PNP A and Small PNP B data points.
The data does not show that transfection efficiency of particles within the claimed particle size range are statistically significant compared to particles outside the claimed range. The error bar for PNP 5 is clear and does not appear to overlap with the error bar for Small PNP B. However, the lower end of the error bar in graph for PNP 1 clearly overlaps with the error bar in the graph for Small PNP B. Error bar for Small PNP A graph is not readily apparent and it is either missing or covered up by the squares. The evidence relied upon should establish that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.
See MPEP 716.02 for the requirements applicant has to meet in order to overcome an obviousness rejection with unexpected results.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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