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 a compound of formula (I) in which variables m and are each one, POLY is pluronic F-127, and AA is lysine in the reply filed on 2026 July 20 is acknowledged. The traversal is on the ground(s) that there is no search burden in a search of formula (I). This argument is persuasive because this formula can be searched in its entirety. Due to no serious burden for searching for a compound of formula (I), all of the claims are examined.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63 / 014756, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 63 / 014756 provides support for composition containing a polymer amino acid conjugate and carboxypolysaccharide but does not discuss the presence of a pharmaceutically active agent in the composition.
Hence the effective filing date of examined application is 2021 April 23.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2024 February 21 was submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is considered by the examiner.
Claim Objections
Claims 4, 5, 12, and 13 are objected to because of the following informalities: the singular and plural tenses regarding an amino acid is not consistent. In claims 1 and 8, an amino acid is defined singularly. In claims 4 and 12, an amino acid is recited plurally. In claims 5 and 13, an amino acid is defined singularly. This issue would be fixed if the amino acids of claims 4 and 12 were defined in a singular tense to be consistent with claims 1 and 8 respectively.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim(s) 1-6 and 8-15 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of written description.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, claims 1-7 and 9-15 are drawn to a method of drug delivery, comprising administering a pharmaceutically active agent and a polymer or composition thereof in powder, solution, or gel form to a wound and the surfaces of surrounding tissue, in which the polymer has a formula shown below:
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Applicants have provided the following definition for a pharmaceutically active agent (page 11, paragraph [0067]). Experimental example 5 describes that paclitaxel, a pharmaceutically active agent, is delivered (page 30, line 1 to page 32, line 28).
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(1) Level of skill and knowledge in the art:
PACHENCE (WO 2004089311, published 2004 November 21) describes that pluronic polyol can be conjugated with proline (page 4, line 17; page 3, lines 18-19). These agents can be administered in liquid, gel, or paste (abstract). These agents are used for the treatment of adhesions and fibrotic diseases (abstract). In this compound, proline is the antifibrotic agent.
(2) Partial structure:
In a compound of formula (I), variable POLY is a triblock copolymer of oxirane and 2-Me-oxirane. At least of variables m and n is one and variable AA is an amino acid.
(3) Physical and/or chemical properties and (4) Functional characteristics:
Experimental examples 1-4 (page 19, line 19 to page 20, last line) describe different properties of the polymer amino acid conjugates. Experimental example 5 describes how paclitaxel, a pharmaceutically active agent, is delivered (page 30, line 1 to page 32, line 28).
(5) Method of making the claimed invention:
Examples 1-5 (specification page 14, line 7 to page 19, line 17) describe how a compound of formula (I) is prepared.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claim(s) 1-7 and 9-15 is/are broad and generic, with respect to all possible compounds encompassed by the claims. The possible structural variations are limitless to any pharmaceutically active agent. Although the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond those compounds specifically disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus. While having written description of the pharmaceutically active agent of paragraph [0067] and paclitaxel and compounds identified in the specification tables and/or examples, the specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the chemical elements of a pharmaceutically active agent. In claim 7 and 16, classes of compounds without any chemical metes and bounds are recited. Only paclitaxel has been clearly defined within the specification as a pharmaceutically active agent.
O’DAY (British Medical Journal, 2013, 346:f3195, 1-7) describes at least three NSAIDS: naproxen, diclofenac, ibuprofen, aspirin, and paracetamol (page 2 of 7, column 2, paragraph 3; page 3 of 7, column 1, last paragraph and column 2, paragraph 9). Do applicants intend for these NSAIDs to be encompassed by the claims?
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 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 11939431. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 16 of US 11939431 is a method of drug delivery using a composition of claims 1-14. A composition of claims 1-14 comprises a polymer amino acid conjugate and a pharmaceutically active agent. Experimental example 5 (column 26, line 23 to column 28, line 16) describes that the hydrogel composition contains paclitaxel, an antineoplastic drug. The composition also contains a carboxypolysaccharide.
Conclusion
Claims 1-16 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: PACHENCE (WO 2004089311, published 2004 November 21) describes that pluronic polyol can be conjugated with proline (page 4, line 17; page 3, lines 18-19). These agents can be administered in liquid, gel, or paste (abstract). These agents are used for the treatment of adhesions and fibrotic diseases (abstract). In this compound, proline is the antifibrotic agent. Hence this is not prior art because a method of examined claim 1 requires a pharmaceutically active agent beside an amino acid conjugated to a pluronic polymer.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 8:00 AM to 4:00 PM.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
