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 .
Withdrawn Objections/Rejections
The objection to claim 1 is withdrawn in view of the claim amendments.
The rejections of claim 3 under 35 U.S.C. § 112(b) are withdrawn in view of the claim amendments.
Claim Status
Applicants' amendments and arguments filed on 05/06/2026 have been fully considered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the
complete set presently being applied to the instant application.
Claims 4-13 and 15 are withdrawn.
Claims 1-3 and 14 are under current examination. The claims were read in view of the species election of a drug of paclitaxel in the response filed 10/01/2025.
New Rejections Necessitated by Claim Amendments
Claim Rejections - 35 USC § 112(a)-New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 3 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
While the specification provides support for a variety of cancer drugs (pg. 3, line 30-pg. 4, line 2; pg. 9, lines 9-13), the specification does not provide support for the inclusion of a cancer drug of doxorubicin, recited in instant claim 3.
Rejections Maintained
Claim Rejections - 35 USC § 102
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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Katsumi et al. (WO
2019/009434 A1, published January 10th, 2019; of record), hereafter “Katsumi”.
Katsumi teaches a drug delivery carrier comprising polymeric micelles formed by self-assembly of a modified dendritic polymer (abstract, claims 1-4). The dendritic polymer is taught to be polyamidoamine (claim 5). The polymeric micelles encapsulate a drug (claim 9) of an anticancer agent (claim 10), and the polymeric micelle is comprised in a medicine (claim 13), a pharmaceutical treatment composition.
Katsumi exemplifies compound 1a (Example 1, paragraph [0113]), a third generation polyamidoamine dendrimer modified with aspartic acid, PEGylated, and bound with a cholesterol residue (cholesterol-modified polyamidoamine-G3). Katsumi further exemplifies polymeric micelles containing compound 1a and the elected species of paclitaxel (Example 2, paragraph [0114]); the paclitaxel is encapsulated (loaded) inside the micelles. The average particle size was 48.28 ± 21.2 nm (paragraph [0115]), and the micelles exemplified by Katsumi are therefore nanoparticles. The PTX-compound 1a micelles suppressed bone cancer growth (paragraphs [0123]-[0124]), and are therefore
interpreted as being formulated for treating cancer.
Claim Rejections - 35 USC § 103
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 1-3 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Katsumi et al.
(WO 2019/009434 A1, published January 10th, 2019; of record), hereafter “Katsumi”.
Katsumi teaches a drug delivery carrier comprising polymeric micelles formed by self-assembly of a modified dendritic polymer (abstract, claims 1-4). The dendritic polymer is taught to be polyamidoamine (claim 5). The polymeric micelles encapsulate a drug (claim 9) of at least one of a therapeutic agent for osteoporosis, a therapeutic agent for rheumatoid arthritis, an anticancer agent, an anti-inflammatory agent, an antioxidant, a nucleic acid drug, a radioactive drug, and a contrast agent (claim 10), and the polymeric micelle is comprised in a medicine (claim 13), a pharmaceutical treatment composition.
Katsumi exemplifies compound 1a (Example 1, paragraph [0113]), a third generation polyamidoamine dendrimer modified with aspartic acid, PEGylated, and bound with a cholesterol residue (cholesterol-modified polyamidoamine-G3). Katsumi further exemplifies polymeric micelles containing compound 1a and the elected species of paclitaxel (Example 2, paragraph [0114]); the paclitaxel is encapsulated (loaded) inside the micelles. The average particle size was 48.28 ± 21.2 nm (paragraph [0115]), and the micelles exemplified by Katsumi are therefore nanoparticles. The PTX- compound 1a micelles suppressed bone cancer growth (paragraphs [0123]-[0124]), and are therefore
interpreted as being formulated for treating cancer.
Katsumi does not exemplify that the composition is formulated for treating or reducing
inflammation (instant claim 14) with sufficient specificity to anticipate, but rather renders obvious a
composition formulated for treating or reducing inflammation. Katsumi teaches the inclusion of a drug
which is at least one of those selected from the group including an anticancer agent and an anti-
inflammatory agent (claim 9-10), and therefore suggests the inclusion of two or more drugs in the
composition; by teaching the inclusion of an anti-inflammatory agent, Katsumi further suggests that the
composition can be formulated for treating or reducing inflammation. It would have been prima facie
obvious to one of ordinary skill in the art before the effective filing date of the instant invention to
follow the suggestion of Katsumi to combine the known elements of an anticancer agent and an anti-
inflammatory agent and predictably achieve a composition with an anti-inflammatory effect.
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 1-3 and 14 are provisionally rejected on the ground of nonstatutory double patenting as
being unpatentable over claims 1-3 of copending Application No. 18/970,049 in view of Katsumi et al.
(WO 2019/009434 A1, published January 10th, 2019; of record), hereafter “Katsumi”.
Claims 1-3 and 14 are directed to an invention not patentably distinct from claims 1-3 of
commonly assigned Application No. 18/970,049.
Both the instant claims and those of copending Application 18/970,049 are directed to a nanoparticle/nanocarrier comprising cholesterol-modified polyamidoamine and a cancer drug of paclitaxel. As the nanocarrier of copending Application 18/970,049 comprises a chemotherapy drug, it is interpreted as a pharmaceutical treatment composition formulated for treating cancer.
The claims of copending Application 18/970,049 do not recite that polyamidoamine is a G3 polyamidoamine, as required by the instant claims. The claims of copending Application 18/970,049 further do not recite that the composition is formulated for treating or reducing inflammation.
Katsumi teaches a drug delivery carrier comprising polymeric micelles formed by self-assembly of a modified dendritic polymer (abstract, claims 1-4). The dendritic polymer is taught to be polyamidoamine (claim 5). The polymeric micelles encapsulate a drug (claim 9) of at least one of a therapeutic agent for osteoporosis, a therapeutic agent for rheumatoid arthritis, an anticancer agent, an anti-inflammatory agent, an antioxidant, a nucleic acid drug, a radioactive drug, and a contrast agent (claim 10). Katsumi therefore suggests the inclusion of two or more drugs in the composition; by teaching the inclusion of an anti-inflammatory agent, Katsumi further suggests that the composition can be formulated for treating or reducing inflammation. Katsumi exemplifies compound 1a (Example 1, paragraph [0113]), a third generation polyamidoamine dendrimer modified with aspartic acid, PEGylated, and bound with a cholesterol residue (cholesterol-modified polyamidoamine-G3). Katsumi further exemplifies polymeric micelles containing compound 1a and the elected species of paclitaxel (Example 2, paragraph [0114]); the paclitaxel is encapsulated (loaded) inside the micelles. The average particle size was 48.28 ± 21.2 nm (paragraph [0115]), and the micelles exemplified by Katsumi are therefore nanoparticles. The PTX-compound 1a micelles suppressed bone cancer growth (paragraphs [0123]-[0124]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the cholesterol-modified polyamidoamine nanocarrier claimed in copending Application 18/970,049 to be a third generation polyamidoamine, as suggested by Katsumi. One would have been motivated to do so to achieve a nanocarrier that is capable of encapsulating paclitaxel and suppressing bone cancer growth, as suggested by Katsumi. It would further have been prima facie obvious to one of ordinary skill in the art to follow the suggestion of Katsumi to combine the known elements of an anticancer agent and an anti- inflammatory agent, both taught by Katsumi to be drugs that can be used in compositions comprising modified polyamidoamine nanoparticles, and predictably achieve a composition with an anti- inflammatory effect.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject
matter of copending Application 18/970,049, the instant claims are rejected on the ground of
nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Application No. 18/970,049, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments
Applicant’s arguments filed 05/06/2026 have been fully considered.
Applicant argues that the prior art of Katsumi does not anticipate nor render obvious the instant claims. Applicant argues that the PAMAM dendrimers are themselves modified with the cholesterol, and are abbreviated PAMAM-Chol NPs in the specification. In contrast, Katsumi first prepares aspartic acid-modified PAMAM, before PEGylation, which is then bound to cholesterol residue, and cannot reasonably be deemed PAMAM-Chol NPs. The present application does not even mention PEGylation or PEG components or aspartic acid modified PAMAM. The present cholesterol-modified PAMAM nanoparticles, required by each pending claim here are not genuinely the same as Katsumi's cholesterol bound PEGylated Asp-PAMA particles.
These arguments are unpersuasive. The Examiner notes that, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Here, the instant claims do not require that cholesterol be directly attached to the PAMAM nanoparticles, nor do they exclude other modifications such as PEGylation or modification with aspartic acid. The specification does not define the term “cholesterol-modified”, and the abbreviation used in the specification does not serve to limit the claim language, which recites the open “comprising” language. The Examiner respectfully maintains, for these reasons and the reasons set forth in the above rejections, that the teachings of Katsumi anticipate the subject matter of claims 1-3, and render obvious the subject matter of claims 1-3 and 14.
Assuming en arguendo that the instant claims require the direct modification of PAMAM nanoparticles, Katsumi explicitly teaches that hydrophobic segments, including cholesterol, can be bound directly or via a linker to terminal groups on the dendritic polymer (see particularly abstract, claim 1, and paragraph [0022]).
Regarding the nonstatutory double patenting rejections, Applicant argues that, as discussed above, Katsumi does not teach or suggest the presently claimed cholesterol-modified PAMAM-G3 nanoparticles, and there is no teaching or motivation for one of skill in the art to combine only the third-generation aspect of Katsumi's particles with any of the claimed particles of the '049 application.
The arguments regarding Katsumi are addressed above. The Examiner respectfully maintains, for the reasons set forth in the above rejections, that the instant claims are unpatentable over claims 1-3 of copending Application No. 18/970,049 in view of the prior art of Katsumi.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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