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 .
Status of the Claims
Claims 1 – 56 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/08/2022 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 8 – 29, 36 – 39, 42 – 56 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
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.
Claims 1 – 7, 30 – 35, and 40 – 41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The following quotation from section 2163 of the Manual of Patent Examination Procedure (MPEP) is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice... reduction to drawings...or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See BU Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
Claims 1 – 7, 30 – 35, and 40 – 41 are rejected as lacking adequate descriptive support for a possession of a polymer comprising a moiety of formula (I).
The structure requires using the genus of any generic hydrophilic polymer – linker – biomolecule composition, but the specification does not provide a representative number of examples of such polymers. The specification presents HAGM cryogels with or without adhesion motifs (GFOGER) and/or T cell-activating biomolecules (aCD3/aCD28Ab) in the Examples, specifically, Example 7, p. 18, lines 15 - 30. No derivatives or variants or mutants thereof are disclosed. Thus, the application fails to provide examples of any species within the claimed genus.
In view of this uncertainty and the lack of a representative number of examples of the claimed genus, the claims are rejected for lack of adequate written description support.
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 7, 34, and 35 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.
Claim 7 recites the limitation "the crosslinks". There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites “wherein the molar ratio of acrylate or methacrylate co- monomer to acrylate or methacrylate groups in the acrylated or methacrylated polysaccharide is at least about 0.1:1.” However, it is not clear what the antecedent and what the consequent of the ratio is. For example, as claimed, the ratio could be acrylate to acrylate of at least 0.1:1; however, it is not clear how a composition of acrylate can be in a ratio with itself.
Claim 35 has a similar issue as claim 34, and in addition, depends from claim 34 and thus inherits the deficiencies of claim 34.
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.
Claims 1 – 7, 30 – 33, and 40 – 41 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by MOONEY (WO 2018/026884 A1, published 02/08/2018; see PTO-892: Notice of References Cited).
The present application is directed to a polymer comprising a moiety of formula (I):
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wherein the hydrophilic polymer is crosslinked to one or more additional hydrophilic polymer molecules, and the linker is covalently attached to the hydrophilic polymer.
MOONEY is directed to a device comprising a delivery vehicle comprising a scaffold composition and any combination of one or more compounds (e.g., one or more adjuvants and/or one or more antigens). See abstract. MOONEY discloses that the scaffold composition comprises a polymer or a co-polymer of alginate, an alginate derivative, gelatin, collagen, agarose, fibrin, dextran, chitosan, carboxymethylcellulose, pullulan, polyethylene glycol (PEG), a PEG derivative, a peptide amphiphile, silk, fibronectin, chitin, hyaluronic acid (see p. 23, lines 12 – 15), and thus, MOONEY’s scaffold discloses the Hydrophilic polymer of formula (I) of claims 1 and 3 – 6.
MOONEY discloses devices comprising a scaffold composition and any one of, or any combination of (e.g., in or on the scaffold composition), the following: (a) at least one antigen; (b) at least one immunostimulatory compound; (c) at least one compound that attracts an immune cell to or into the delivery vehicle; (d) at least one compound that induces immunogenic cell death of a tumor cell; (e) at least one compound that inhibits T-cell or dendritic cell suppression; and/or (f) at least one compound that inhibits an immune-inhibitory protein and that the antigen comprises (i) a polypeptide comprising amino acids in a sequence found within an oncoprotein, and (ii) an epitope (e.g., a CD4 epitope) derived from a pathogen (e.g., a virus such as measles) or another highly immunogenic polypeptide, wherein (i) and (ii) are connected by a linker (see p. 7, lines 4 – 8), and thus MOONEY discloses the Linker and Biomolecule of formula (I) of claim 1.
MOONEY teaches that the scaffold composition comprises a hydrogel or a cryogel (see p. 23, lines 4 – 5) and that a hydrogel comprises an interconnected network of plurality of polymers, e.g., including a first polymer and a second polymer(see p. 104, lines 19 – 20) and that the hydrogel (e.g., cryogel) comprises a crosslinked gelatin polymer or a crosslinked alginate polymer (see p. 106, lines 3 – 4), and thus, MOONEY discloses “wherein the hydrophilic polymer is crosslinked to one or more additional hydrophilic polymer molecules” of present claim 1.
Finally, MOONEY teaches that one or more compounds disclosed are covalently or noncovalently linked or attached to the scaffold composition, and thus MOONEY discloses that “the linker is covalently attached to the hydrophilic polymer” of present claim 1.
In view of MOONEY’s disclosure, MOONEY’s device anticipates claims 1 – 6.
Regarding claim 7, MOONEY discloses that “the polymers in the hydrogel are 50-100% crosslinked ( covalent bonds)”.
Regarding claims 30 – 32, MOONEY discloses that the scaffold composition comprises a polymer or a copolymer of a natural or synthetic polysaccharide (see p. 23, lines 12 – 16) and that the polymer or copolymer is methacrylated (see p. 23, line 28). Furthermore, MOONEY discloses that “the cryogel is further functionalized by the addition of a further cross-linker agent (e.g. multiple arms polymers, salts, aldehydes, etc.). The solvent can be aqueous”. See p. 109, line 32 – p. 110, line 2.
Regarding claim 33, because a co-monomers are co-polymerized with monomers to create a copolymer, MOONEY’s methacrylated copolymer anticipates the result of the claimed method “wherein the acrylated or methacrylated polysaccharide is reacted with an acrylate or methacrylate co-monomer”.
Regarding claims 40 - 41, MOONEY discloses that in an exemplary synthesis process, (i) Alginate (a naturally occurring, biocompatible polysaccharide) is chemically modified to allow radical polymerization, (ii) Methacrylated (MA)-alginate is added to ammonium persulfate (APS)/ tetramethylethylenediamine (TEMED) initiator system before incubation at -20 °C to allow ice crystal formation. See p. 43, lines 14 – 18.
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 – 7, 30 – 35, and 40 – 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 12 of U.S. Patent No. 8,529,897 in view of MOONEY.
Patented claim 1 recites a composition comprising: a hyaluronan matrix; and a monoclonal antibody directly conjugated to the hyaluronan matrix, wherein the antibody is selected from the group consisting of an anti-IL-1β, an anti-TNF-α, and combinations thereof.
The main difference between the present claims and the patented claims is that the present claims recite a linker (claim 1) and a method of making a cryogel (claim 30). However, MOONEY discloses this difference. The teachings of MOONEY, and how they relate to the claims, are set forth in the rejections under 35 U.S.C. 102 above.
Because the patented claims recite a hydrophilic polymer connected to a biomolecule and MOONEY discloses the linker of formula (I) of present claim 1 and discloses a method of making a cryogel of claim 30, it would have been obvious to one having ordinary skill in the art to use the structure of the patented claims with the linker of MOONEY and MOONEY’s method of making. There would have been a reasonable expectation of success given that the structure of formula (I) has been known to be a successful pharmaceutical configuration as evidenced by the applied prior art.
Claims 1 – 7, 30 – 35, and 40 – 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 13 of U.S. Patent No. 11,850,325 in view of MOONEY.
Patented claim 1 recites a compound of formula (I), or a pharmaceutically acceptable salt thereof:
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wherein L represents a polymeric linking moiety; and Ra represents H, (C1-C6)alkyl, or phenyl.
Patented claims 2 – 4 each recites a linking moiety or a linker.
Patented claim 5 recites a cryogel, comprising: a residue of a compound of claim 1; and
a hydrophilic bio-compatible polymer;
Patented claim 6 recites the cryogel of claim 5, wherein the residue of a compound of claim 3 is crosslinked to the hydrophilic bio-compatible polymer; and
Patented claim 7 recites the cryogel of claim 5, wherein the hydrophilic bio-compatible polymer is selected from the group consisting of a gelatin-based bio-compatible polymer and a hyaluronic acid-based bio-compatible polymer.
The main difference between the present claims and the patented claims is that the present claims recite a biomolecule (claim 1) and a method of making a cryogel (claim 30). However, MOONEY discloses this difference. The teachings of MOONEY, and how they relate to the claims, are set forth in the rejections under 35 U.S.C. 102 above.
Because the patented claims recite a hydrophilic polymer and a linker and MOONEY discloses the biomolecule of formula (I) of present claim 1 and discloses a method of making a cryogel of claim 30, it would have been obvious to one having ordinary skill in the art to use the structure of the patented claims with the biomolecule of MOONEY and MOONEY’s method of making. There would have been a reasonable expectation of success given that the structure of formula (I) has been known to be a successful pharmaceutical configuration as evidenced by the applied prior art.
Claims 1 – 7, 30 – 35, and 40 – 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36, 59, 70, and 71 of copending Application No. 17/600,198 in view of MOONEY.
Copending claim 36 recites a hypoxia-inducing cryogel comprises: one or more polymers; one or more hypoxia-inducing agents; andcatalase (CAT);wherein the one or more hypoxia-inducing agents and CAT are each independently covalently attached to at least one polymer of the one or more polymers.
Copending claim 59 recites that the one or more polymers are independently selected from the group consisting of a DNA strand, a peptide, a protein, alginate, hyaluronic acid, chitosan, heparin, carboxymethyl cellulose, cellulose, carob gum,hyaluronic acid glycidyl methacrylate (HAGM), methacrylated gelatin, methacrylated alginate, poly(ethylene glycol) (PEG), acrylate-PEG, methacrylate-PEG, PEG-co- poly(glycolic acid), PEG-co-poly(L-lactide), poly(2-hydroxyethyl methacrylate) (pHEMA),poly-2-hydroxyethylacrylate (polyHEA), polyacrylamide (PAAm), and poly(N- isopropylacrylamide) (PNIPAAm), and copolymers and combinations thereof.
Copending claim 70 recites that the hypoxia-inducing cryogel further comprises a bioactive molecule.
The main difference between the present claims and the copending claims is that the present claims recite a linker (claim 1) and a method of making a cryogel (claim 30). However, MOONEY discloses this difference. The teachings of MOONEY, and how they relate to the claims, are set forth in the rejections under 35 U.S.C. 102 above.
Because the copending claims recite a hydrophilic polymer connected to a biomolecule and MOONEY discloses the linker of formula (I) of present claim 1 and discloses a method of making a cryogel of claim 30, it would have been obvious to one having ordinary skill in the art to use the structure of the copending claims with the linker of MOONEY and MOONEY’s method of making. There would have been a reasonable expectation of success given that the structure of formula (I) has been known to be a successful pharmaceutical configuration as evidenced by the applied prior art.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/ESTELLA M. GUSTILO/Examiner, Art Unit 1646 /JANET L EPPS -SMITH/Supervisory Patent Examiner, Art Unit 1646