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
Applicant's election with traverse of Group I, drawn to a pharmaceutical treatment composition, in the reply filed on 10/01/2025 is acknowledged. Applicant’s further election with traverse of the species of a drug of paclitaxel in the reply filed on 10/01/2025 is acknowledged
The traversal is on the grounds that once the composition claims, including drugs known for treating certain conditions, are considered for patentability, consideration of the method claims for using those composition in treating those conditions would follow without the need for significant, if any, additional searching or consideration.
This is not found persuasive because per PCT rule 13.1 and 13.2, search burden is not a criterion for lack of unity of invention. As set forth in the Requirement for Restriction mailed 08/08/2025, the groups of inventions do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical feature, as the shared technical feature does not make a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-13 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 10/01/2025.
Claims 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the election requirement in the reply filed on 10/01/2025.
Claims 1-3 and 14 are under current examination.
Priority
This application is a national stage entry of PCT/US2021/046153, filed 08/16/2021. Priority has been claimed to US PRO 63/079,528, filed 09/17/2020 and US PRO 63/065,806, filed 08/14/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/08/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: “polyamidoamine-03” in line 2 appears to be a typographical error of “polyamidoamine-G3”, as it appears in the originally filed claims and throughout the specification. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 3 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 3 recites the limitation "The cancer treatment composition as recited in claim 2" in line 1. There is insufficient antecedent basis for this limitation in the claim. While claim 2 recites that the composition is formulated for treating cancer, claim 2 recites a pharmaceutical treatment composition and not a cancer treatment composition. It is suggested that Applicant can amend claim 3 to recite “The pharmaceutical treatment composition as recited in claim 2”.
Claim 3 further recites “at least one cancer drug selected from the group consisting of coxorubicin…”; it is unclear what compound “coxorubicin” is intended to refer to, as this is not a term known in the art as a cancer drug.
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), 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), 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), 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.
Conclusion
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.
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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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/J.M.K./Examiner, Art Unit 1611
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611