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 .
The examiner acknowledges receipt of response to election/restriction requirement filed 07/22/2026 and IDS filed 09/13/2024.
Receipt is also acknowledged for preliminary amendment filed 05/24/2024. Claims 1-15 are amended. New claims 16-21 are added.
Claims 1-21 are pending.
Election/Restrictions
Applicant elects composition that reads n claims 10, 16, 17 and 19, polymer which is part of the composition is also elected. Applicant also elected NH4OH (ammonium hydroxide) and tetraethyoxysilane (TEOS) as metal oxide. However, NH4OH (ammonium hydroxide) polycondensation catalyst and tetraethyoxysilane (TEOS) as metal oxide are used in the polymer production method and not part of the elected composition. Claim 10 depends on claim 7 which depends on claim 1. Claims 1 and 7 and method claims producing the polymer present in the claimed composition of claim 10. Thus claim 10 is a product claim in which the polymer in the composition is produced by the method of claims 1 and 7. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (MPEP 2113 [R-01.2024].
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See also Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009), Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020), United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360, 1373, 2023 USPQ2d 862 (Fed. Cir. 2023). In the instant case claim 10 fully defines the composition comprising a polymer or particle and pharmaceutically acceptable excipient, cosmetic acceptable excipient, an agricultural acceptable excipient or combination thereof.
Therefore, because composition is elected, claims 10, 16, 17 and 19 identified by applicant are under examination.
Election was not made with or without traverse. Applicant did not also argue that the election of species is improper. Therefore, because applicant did not distinctly and specifically point out the supposed errors in the election/restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-9, 11-15, 18 and 20-21 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventive species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/22/2026.
Priority
This application is a 371 of PCT/NL2022/050593 filed 10/19/2022 and which claims benefit of EP application 21203511.7 filed 10/19/2021.
Information Disclosure Statement
The IDS filed 09/13/2024 has been considered by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 10 depends on claim 7 which depends on claim 1. Claims 1 and 7 and method claims producing the polymer present in the claimed composition of claim 10. Thus claim 10 is a product claim in which the polymer in the composition is produced by the method of claims 1 and 7. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (MPEP 2113 [R-01.2024].
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See also Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009), Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020), United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360, 1373, 2023 USPQ2d 862 (Fed. Cir. 2023). In the instant case claim 10 fully defines the composition comprising a polymer or particle and pharmaceutically , cosmetic acceptable excipient, an agricultural acceptable excipient or combination thereof.
Claim(s) 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CHAKRAPANI et al., (WO 2009134769 A1).
Claim 10 is a composition comprising polymer and pharmaceutically acceptable excipient, cosmetic acceptable excipient or agriculturally acceptable excipient.
For claim 10, CHAKRAPANI teaches the nanoparticulate compositions comprising biodegradable polymer, pharmaceuticals namely polysaccharide containing antigen, polynucleotide containing antigen, single stranded RNA, and others (abstract; page 2; 3rd full paragraph of page 5; section 1 at pages 17-23, ) and excipients namely binders, disintegrants, diluents, lubricants, suspending/dispersing agents (page 16, 1st full paragraph). Binders and disintegrants and diluents and lubricants meet the limitation of pharmaceutically acceptable excipients.
Thus, CHAKRAPANI teaches claim 10.
Claim(s) 10, 16 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GOODMAN et al. (WO 2021113777 A2).
For claim 10, GOODMAN discloses composition comprising circular RNA polynucleotide and transfer vehicles/nanoparticles/lipid nanoparticle (see the whole document with emphasis on the abstract, paragraphs [0006], [0007], [0145]); the transfer vehicle comprises ionizable lipid, PEG modified lipid (paragraphs [0006], [0039], [0041], [0044], [0145], [0146], [0156], [0234], [0579]-[0593 page 205, lines 4-29, claims 68, 75, 79, 80, 184); the nanoparticle is lipid nanoparticle or polymer nanoparticle or biodegradable polymer nanoparticle (paragraphs [0079], [0145], [0173]); the transfer vehicle includes any one of the standard pharmaceutical carriers, diluents, excipients (paragraphs [0202], [0640], [0651], [0657], [0670]).
For claim 16, the composition of GOODMAN is in the form of a film (paragraph [0617]).
For claim 19, GOODMAN administers the composition by subcutaneous injection (paragraph [0069]) or intramuscular injection (paragraph [0779]). See also paragraphs [0656]-[0661]).
Therefore, GOODMAN teaches all the elements of claims 10, 16 and 19.
Claim(s) 10, 16, 17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by MUNDADA et al. (US 20170290807 A1).
MUNDADA teaches film composition comprising Ondansetron or its pharmaceutical salt (see the whole document with emphasis on the abstract), water-soluble polymer that is a combination of hydrophilic cellulosic polymers, maltodextrin and polyethylene oxide which meets the limitation of polymer, plasticizer and at least one excipient selected from colorants, flavoring agents, sweeteners and ion-exchange resins all of which are pharmaceutically acceptable or cosmetic excipients (paragraphs [0034]-[0038], [0051]-[0066]). In one embodiment, MUNDADA administers the film composition top the tongue of a patient (paragraphs [0051], [0118]) and the administration to the tongue is a local administration meeting the mode of administration of the film composition of claim 19. The film composition of MUNDADA comprising Ondansetron, pharmaceutically acceptable excipient and polymer anticipates the claimed composition in claims 10 and 16. MUNDADA during the preparation transfers the obtained film composition onto polyester films (paragraphs 90076], [0108] and claim 6). Transferring the composition onto the polyester film meets the limitation in claim 17 that the composition is located on top of one or both sides of the film.
Therefore, MUNDADA teaches all the elements of claims 10, 16, 17 and 19.
No claim is allowed.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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