--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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 23, 2026 has been entered.
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. Claim 70 was newly added and reads on the elected invention. Claims 1-28, 30-39, 41, 43-51, 56, 57, 59, 62-64, and 66-69 were cancelled. Claims 29 and 65 were 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 Claims 52-55, 58, 60, and 61 are withdrawn.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 - of record in IDS dated 11/08/2024), Muppalla (Wiley Periodicals, Inc., 2012, 1637-1650 – of record in PTO-892 dated 08/06/2025), and Trieu (US 2016/0151498 A1 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
PNG
media_image1.png
136
195
media_image1.png
Greyscale
. In some embodiments, the second capping unit is of the formula A
PNG
media_image2.png
75
97
media_image2.png
Greyscale
where R 1s -SC2-C12 alkyl or C6Hs (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 1 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 to 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 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 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
PNG
media_image3.png
192
275
media_image3.png
Greyscale
as the endcap of the first block and having
PNG
media_image4.png
117
151
media_image4.png
Greyscale
where R is -SC2-C12 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 Langi, 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 l.32l(c) or l.32l(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 l.32l(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 LB. I.
For a reply to a non-final Office action, see 37 CFR 1.11 l(a). For a reply to final Office action,
see 3 7 CFR 1.113 ( c). A request for reconsideration while not provided for in 3 7 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/ AIN26) 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 autoprocessed
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 diblock 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 February 23, 2026 were fully
considered but are not persuasive for the following reasons.
Applicant’s argument that there would not have been a reasonable expectation of success in arriving at the claimed invention is not persuasive because 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 reference 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 decision in In HZNP Medicines LLC v. Actavis Laboratories UT, Inc. was reviewed, however it is not analogous to present rejection because the present rejection is not based on optimization of a result-effective variable.
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.
“DISCLOSURE STATEMENT" in the remarks is acknowledged, however the references were not considered because the list is not a proper information disclosure statement. See 37 CFR 1.97 and 1.98.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Alma - Pipic whose telephone number is (571)270-7459. The
examiner can normally be reached M-F 9:00am-5:00pm. Examiner interviews are available via
telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration
tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview
Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's
supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the
organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from
Patent Center. Unpublished application information in Patent Center is available to registered
users. To file and manage patent submissions in Patent Center, visit:
https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more
information about Patent Center and https://www.uspto.gov/patents/docx for information about
filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC)
at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service
Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALMA PIPIC/Primary Examiner, Art Unit 1617