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 .
Claim Status
Claims 1-20 are rejected.
No claims are allowed.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. JP2022-165423, filed on 14-Oct-2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 11-Apr-2025 has been considered by the examiner.
Claim Rejections - 35 USC § 112
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.
Claim 2 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. The phrase “as long as an atomic valence is allowed” is indefinite. A person having ordinary skill in the art would not be able to determine the resultant “where a is an integer of 2 or more, two or more Ya2's may be the same as or different from each other, and in a case where b is an integer of 2 or more, 2 or more Yb2's may be the same as or different from each other and 2 or more Rb3's may be the same as or different from each other” since Ya2’, Yb2’, and Rb3’ are not recited in the claim nor structure.
Claim 5 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. The claim limitation recites “selected from the group consisting of an ether bond, an ester bond, a urethane bond, and an amide bond”. An ether, ester, urethane, and amide are chemical functional groups or linkage, not a bond itself. Equating bonds directly to “organic group” create indefiniteness regarding what structure are encompassed with the metes and bounds of the limitation.
Claim 9 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. The claim limitation recites “a and b each independently represents an integer of 1 to 30” and ends in a closing bracket. The syntax creates ambiguity in the claim language.
Claim 18, 19, and 20 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. The claim limitations recites “General Formulae” when introducing singular specific formula. The term formulae is plural and introduces confusion on the metes and bounds of the limitation.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
1. Claim(s) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toyoshima et al. (Biological specific recognition of glycopolymer-modified interfaces by RAFT living radical polymerization, Published 23-Dec-2009) (hereinafter Toyoshima), and further in view of Ise et al. (Improved Isolation of Mesenchymal Stem Cells Based on Interactions between N-Acetylglucosamine-Bearing Polymers and Cell-Surface Vimentin, Published: 2019) (hereinafter Ise).
With regard to claim 1, Toyoshima discloses a copolymer comprising a constitutional unit comprising a saccharide group and a structurally distinct constitutional unit containing a structure represented by instant General Formula (b), “A mixture of the corresponding sugar monomer, AAm, an initiator (2.2’-azobis(2-amidinopropane)dihydrochloride, RAFT reagent and solvent in a Pyrex tube was degassed by three freeze-thaw cycles. The tube was sealed under vacuum and heated at 60 1C with occasional agitation. Polymerization was terminated by cooling the tube, and the product was precipitated in acetone and collected by centrifugal sedimentation” (Page 173, General procedure for polymerization) as demonstrated in the reaction scheme:
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Toyoshima further teaches that the copolymerization was obtained using a specifically fixed sugar to monomer to acrylamide feed ratio of 0.030 mmol to 0.27 mmol, respectively, across 6 runs (Page 174, Table 1):
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However, Toyoshima differs from the instant claims by teaching galactose and mannose derivatives instead of N-acetylglucosamine group as a compositional unit, and Toyoshima does not disclose administering the copolymer to a living body or any myofibroblast inactivation. For this reason, Ise is added.
Ise discloses a RAFT synthesized polymer with N-acetylglucosamine that binds cell surface vimentin on fibroblast lineage cells, “We have found that vimentin on the surfaces of several cell types possesses N-acetylglucosamine- (GlcNAc-) binding activity [26–29]. Moreover, multiple GlcNAc-bearing polymers interact with cancer cells, fibroblasts, and skeletal muscle cells via cell-surface vimentin [29, 30]. The latter half of the vimentin rod II domain has been identified as the GlcNAc-binding domain” (Page 2, Introduction). Ise further discloses that the N-acetylglucosamine reduces the proliferation and adhesion of bound fibroblasts, demonstrating biological effect on target cells, “A reduction in the proliferation rate was observed in cells from tissue-culture dishes but not from those on AC-GlcNAc-coated dishes (Figure 3(c)). Therefore, we assessed senescence by measuring senescence-associated β-galactosidase (SA-βGal) activity” (Page 8, 3.5. Cellular Senescence in Proliferating Cells Is Reduced by Isolation on AC-GlcNAc-Coated Dishes.).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the N-acetylglucosamine glycomonomer of Ise for the derivative galactose and mannose glycomonomer of Toyoshima with the acrylamide copolymerization method that Toyoshima discloses, and to bring the vimentin expressing fibroblast lineage cells to obtain the binding and anti-proliferative effects that Ise attributes to N-acetylglucosamine bearing polymers. This modification arrives at instant claim 1, with a copolymer having constitutional unit (a) GlcNAc and constitutional unit (b) acrylamide derived Formula (b), administered to inactivate myofibroblasts. Toyoshima demonstrates why this would have been obvious in that two chemically distinct saccharides under the identical polymerization process were able to be attached without modification, demonstrating that the identity of the saccharide is a variable readily exchanged in the copolymer structure. Substituting one art recognized glycomonomer for another within a known copolymer in order to redirect the resulting copolymer’s known binding specificity towards a different target, in this case, vimentin expressing myofibroblast lineage cells. This represents simple substitution of one known element for another to obtain predictable results. See MPEP 2143 (I)(B).
A person having ordinary skill in the art would have had a reasonable expectation of success in this substitution since Ise confirms that N-acetylglucosamine bearing monomers are synthesized and polymerized by the same class of RAFT chemistry as shown in Toyoshima. The resultant copolymer, contacted with myofibroblasts or myofibroblast lineage cells via the disclosed vimentin binding mechanism would inactivate the cells within the instant claim, since Ise discloses that this interaction produces reduced proliferation and altered the senescence markers in the bound rate. Further, because Ise is directed towards an acylate conjugated glycomonomer and because Toyoshima’s method already accommodates distinct sugar monomer without alteration of the reaction conditions, a person of ordinary skill would reasonably expect that substituting GlcNAc monomer for Toyoshima’s sugar monomer would be successful in comparable reaction conditions without undue experimentation, and would predictably yield a copolymer containing GlcNAc’s known vimentin binding activity.
With regard to claim 2, the teachings of Toyoshima and Ise are discussed supra. Toyoshima discloses that Rb1 and Rb2 are each a hydrogen atom or an organic group, and that Yb1 is -C(=O)-O- -C(=O)-NH-, satisfied by the acrylamide derived pendent group formed upon the polymerization of the AAm comonomer.
With regard to claim 3, the teachings of Toyoshima and Ise are discussed supra. Toyoshima and Ise teaches Ya2 and Ya3 as a linking group, and Rb3 represents an organic group and is satisfied by the acrylamide derived pendent group.
With regard to claim 4, Table 1 of Toyoshima discloses a saccharide monomer to acrylamide molar feed ratio of 0.030 mmol to 0.27 mmol ~1:8 for each of the six runs. This is within the instantly claimed range of 10:1 to 1:20 (Page 174, Table 1):
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With regard to claim 5, the teachings of Toyoshima and Ise are discussed supra. The pendent amide bond of Toyoshima as previously discussed satisfies the instant claim limitation that Rb2 “includes at least one organic group selected from the group consisting of an ether bond, an ester bond, a urethane bond, and an amide bond”.
With regard to claim 6-7, the teachings of Toyoshima and Ise are discussed supra. Further, Figure 1 of Ise depicts the structure of the AC-GlcNAc in which N-acetylglucosamine is conjugated through an amide bond onto a pendant arm terminating in an ester linkage to the polymer backbone. The structure of the N-acetylglucosamine disclosed in Ise corresponds to the structure of Formula (a1-1-1) of instant claim 6 and Formula (a-1-1) of instant claim 7 (Page 3, Figure 1):
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With regard to claim 8, the teachings of Toyoshima and Ise are discussed supra. Toyoshima disclosed that constitutional unit (b) is a constitutional unit derived from acrylamide, since Toyoshima discloses “A mixture of the corresponding sugar monomer, AAm …” (Page 173, General procedure for polymerization).
With regard to claim 9 and 18, the teachings of Toyoshima and Ise are discussed supra. Ise discloses a polymer backbone derived from an initiator RAFT agent fragment in Figure 1 (Page 3, Figure 1):
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The figure disclosed by Ise corresponds to instant Formula (C-1) (cf. claim 9) and Formulae (C1-1) (cf. claim 18), terminating in a dodecyl trithiocarbonate group, consistent with RAFT reagent, “AC-GlcNAc monomers were polymerized by 2,2’-azobis(isobutyronitrile) (AIBN; Tokyo Chemical Industry Co., Ltd., Tokyo, Japan) as an initiator and 2-(dodecylthiocarbonothioylthio)-2-methylpropanoic acid (DTMPA; Sigma, St. Louis, MO, USA) as the RAFT reagent” (Page 2, 2.1. Preparation of Polymers and Recombinant Vimentin for Coating Culture Dishes.).
Alone, Ise discloses only the backbone, the terminus, and GlcNAc pendent structure solely as a homopolymer without a secondary structurally distinct constitutional unit (b). Toyoshima, as previously discussed in claim 1 above, discloses copolymerizing saccharide-glycomonomer with an acrylamide to form a second distinct constitutional unit bearing a pendant carboxamide group. For the same reasons set forth in claim 1, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the backbone, terminus, GlcNAc group of constitutional unit (a) with Toyoshima’s acrylamide derived constitutional unit (b) to arrive at a copolymer of Formula (C-1).
With regard to claim 10-12, the teachings of Toyoshima and Ise are discussed supra. Toyoshima discloses in Table 1 six runs of the copolymerization process (Page 174, Table 1):
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Of the six runs, the molecular weight ranged from 5.3 to 12 (5,300-12,000 Mn) and the Mw/Mn ranging from 1.2 to 1.4. These disclosed values overlap within the instantly claimed ranges of Mw 2,000-20,000, 2,000-15,000, and Mw/Mn from 1.0-1.7.
With regard to claim 13-14, the teachings of Toyoshima and Ise are discussed supra. Ise discloses that the GlcNAc bearing polymer binds directly to cell surface vimentin on fibroblast lineage cells through the specific molecular mechanism of claim 1. Ise discloses “We have found that vimentin on the surfaces of several cell types possesses N-acetylglucosamine- (GlcNAc-) binding activity [26–29]. Moreover, multiple GlcNAc-bearing polymers interact with cancer cells, fibroblasts, and skeletal muscle cells via cell-surface vimentin [29, 30]. The latter half of the vimentin rod II domain has been identified as the GlcNAc-binding domain. It is expressed on the cell surface as tetrameric, but not filamentous, forms of vimentin” (Page 2, Introduction). Ise further confirms that this binding is confirmed via Western blots and cell adhesion assay of biotinylated cell surface vimentin (Page 2, 2.2. Evaluation of AC-GlcNAc-Coated Dishes, and 2.3. Cell Adhesion Assay.).
With regard to claim 15-17, the teachings of Toyoshima and Ise are discussed supra. Ise further discloses a C12H25 dodecyl group forming part of the RAFT agent as the polymer terminus (Page 3, Figure 1). The discloses dodecyl group overlaps with the instantly claimed range of 1 to 12 carbons for Rb1 (cf. claim 15), 1 to 20 carbons for Rb2 (cf. claim 16), and 1 to 20 carbons for Rb3 (cf. claim 17).
2. Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toyoshima et al. (Biological specific recognition of glycopolymer-modified interfaces by RAFT living radical polymerization, Published 23-Dec-2009) (hereinafter Toyoshima) in view of Ise et al. (Improved Isolation of Mesenchymal Stem Cells Based on Interactions between N-Acetylglucosamine-Bearing Polymers and Cell-Surface Vimentin, Published: 2019) (hereinafter Ise), and further in view of Duan et al. (Multi-arm polymeric nanocarrier as a nitric oxide delivery platform for chemotherapy of head and neck squamous cell carcinoma, Published: 26-Jan-2012) (hereinafter Duan) and Suljovrujic et al. (Smart poly(oligo(propylene glycol) methacrylate) hydrogel prepared by gamma radiation, Published: 2014) (hereinafter Suljovrujic).
With regard to claim 19, the teachings of Toyoshima and Ise are discussed supra. The combination of Toyoshima and Ise renders Formula (C-1) obvious.
However, neither Toyoshima nor Ise discloses that the pendant oxygen of constitutional unit (b) comprises a branch comprising a plurality of release oligo(oxyalkylene) unites terminating in a methyl group as recited in Formula (c-3) and Formula (C1-3). For this reason, Duan and Suljovrujic are added.
Duan discloses that the motivation for appending a hydrophilic oligomeric branch onto a polymer scaffold is directed towards biological uses. “The spherical multi-arm polymer has a compact structure, low polydispersity index and large surface area, making it an ideal candidate for drug delivery applications. In addition, the presence of a number of sugar molecules on the polymer chains effectively converts a hydrophobic synthetic polymer into a highly water-soluble and non-toxic polymer due to the ease of degradation of the sugar braches by the naturally-occurring enzymes in vivo” (Page 3250, Discussion).
Suljovrujic discloses that a methacrylate ester bearing a repeating oligo(propylene glycol) methacrylate reagent OPGMA (Page 207, 2.1. Materials) and reports that a polymer built with this branch structure exhibits favorable in vitro biocompatibility. “In the in vitro study of biocompatibility via a cytotoxicity assay… As the cell viability for POPGMA sample was greater than 50%, it could be considered non cytotoxic” (Page 212, Results and Discussion).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to attach an oligo(alkylene oxide) methacrylate branch as disclosed by Suljovrujic onto the pendant oxygen of constitutional unit (b) of the Formula (C-1) copolymer, and using the branch appending approach in Duan to arrive at a copolymer within the scope of Formula (C-3) and Formulae (C1-3). A person having ordinary skill in the art seeking to improve the biocompatibility or aqueous solubility of the GlcNAc and acrylamide copolymer of Formula (C-1) would have been motivated to incorporate a branch structure that is independently demonstration by Suljovrujic to confer non-cytotoxic and non-hemolytic behaviors onto the polymer bearing it, using the general branch appending strategy of Duan demonstrates to achieve the same class of biocompatibility improvements on a comparable RAFT type polymer scaffold. This represents combining prior art elements according to known methods to yield predictable results. See MPEP 2143 (I)(A).
A person of ordinary skill would have had a reasonable expectation of success because Suljovrujic’s OPGMA branch is a methacrylate ester linked pendant group directed in the general genus of ester linkages already present at constitutional unit (b)’s pendant group oxygen in Formula (C-1) such that esterification of the branch onto the pendant oxygen involves only the esterification and methacrylate branch conjugation demonstrated in the art. Duan further confirms that this general category of modification, such as appending a hydrophilic pendant branch to alter a RAFT type polymer’s solubility and biocompatibility is a routine technique in polymer class, further supporting a reasonable expectation that the specific branch of Suljovrujic could be incorporated successfully using the same general approach.
3. Claim(s) 9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toyoshima et al. (Biological specific recognition of glycopolymer-modified interfaces by RAFT living radical polymerization, Published 23-Dec-2009) (hereinafter Toyoshima) in view of Ise et al. (Improved Isolation of Mesenchymal Stem Cells Based on Interactions between N-Acetylglucosamine-Bearing Polymers and Cell-Surface Vimentin, Published: 2019) (hereinafter Ise), and further in view of Duan et al. (Multi-arm polymeric nanocarrier as a nitric oxide delivery platform for chemotherapy of head and neck squamous cell carcinoma, Published: 26-Jan-2012) (hereinafter Duan).
With regard to claim 20, the teachings of Toyoshima and Ise are discussed supra.
However, the combination of Toyoshima and Ise does not disclose the structure of Formula (C-5) and Formulae (C1-8). For this reason, Duan is added.
Duan teaches “[t]he MADIX/RAFT agent was synthesized based on the procedure reported previously (Fig. 2) [30]. Pentaerythritol was used as the starting material to react with 2-bromopropionyl bromide and O-ethylxanthic acid (potassium salt) successively to form a four-arm sulfur compound which was used as the MADIX/RAFT initiator agent” (Page 3244, 2.2.1. Synthesis of MADIX/RAFT agent) (Page 3245, Figure 2):
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Duan further teaches that the arm population of the pentaerythritol core can be functionalized nonuniformly by reacting the core with differing concentrations of succinic anhydric: “Polymers with increasing degree of succination (20%, 40%, 60% and 90%) were generated by reacting the star poly-(6-O-methacryloyl-D-galactose) (100 mg) with succinic anhydride (20, 40, 60 and 90 mg, respectively) in 20 mL of dry dimethyl formaldehyde (Fig. 3)… Lyophilization of the resulting solution led to the desired sugar multi-arm polymers with increasing substitution degrees of carboxylic acids. (Page 3244-3245, 2.2.3. Modification of multi-arm poly-(6-O-methacryloyl-D-galactose) with succinic anhydride). Thus, Duan teaches that the arm population of the core were subsequently subjected to an arm modifying reaction to install distinct terminal groups across the structure with varying degrees of substitution.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to build the GlcNAc terminal arm of Toyoshima and Ise upon the branched pentaerythritol core taught by Duan, functionalizing three of the arms with the GlcNAc terminal arm and leaving the fourth arm bearing a non-GlcNAc terminal arm, arriving at the composition of Formula (C-5) and Formulae (C1-8). Duan already establishes that a skilled artisan routinely varies the degree and identity of the terminal functionalization across the arm population of a pentaerythritol core by using controlled substitution as a design variable rather than uniform functionalization for every arm. A person having ordinary skill in the art seeking to build a multivalent GlcNAc terminal arm, already rendered obvious by Toyoshima and Ise, would have been motivated to apply Duan’s known multi-arm, partial substitution core structure to that arm chemistry, distributing the GlcNAc terminal arm across three of the four available core positions while leaving one position for a different terminal group, exactly as Duan demonstrates is a routine design choice for this core.
A skilled artisan would have had a reasonable expectation of success because Duan’s pentaerythritol core is functionalized using the general class of reagents such as RAFT, and conjugation chemistry is demonstrated in Toyoshima and Ise to be compatible with the GlcNAc arm formations, and because Duan demonstrates that partial functionalization of a subset of a multi-armed core is a routinely achieved outcome through the prior art’s esterification and conjugation techniques. Applying the specific GlcNAc conjugation chemistry of Ise to three of Duan’s four pentaerythritol arm positions, while leaving the fourth arm with a different terminal group represents the combination of two prior art elements according to known methods to yield predictable results. See MPEP 2143 (I)(A).
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.
Claim 1 and 14 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/775864. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application recites “A method for using a polymer comprising an N-acetylglucosamine unit and a carboxy group-containing radically polymerizable unit as an O-GlcNAcylated protein-like substance comprising administering the polymer to a subject in need thereof, wherein the polymer includes 3 to 100 N-acetylglucosamine groups per molecule.” This claim, at the genus level, recites the two-component polymer administered to a subject in need thereof that forms the basis of instant claim 1 and constitutional unit (b) for Formula (b). and the instant claim 14 which recites binding the copolymer to myofibroblasts. Instant claims 1 and 14 are not patentably distinct from claim 1. A subject in need of the administered O-GlcNAcylated protein like substant, with meaning of Application No. 17/775864 is disclosed by to be the very condition addressed in instant claim 1 and 14.
Claim 13 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/775864. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application recites in claims 5 and 6: “An oral or parenteral dosage form comprising a polymer comprising an N-acetylglucosamine unit and a carboxy group-containing radically polymerizable unit as an active ingredient, and a pharmaceutically acceptable carrier; wherein the polymer includes 3 to 100 N-acetylglucosamine groups per molecule.” and “A method for treating fibrosis comprising administering to a subject in need thereof a polymer comprising an N-acetylglucosamine unit and a carboxy group-containing radically polymerizable unit, wherein the polymer includes 3 to 100 N-acetylglucosamine groups per molecule.” Instant claim 13 recites a method of treatment for fibrosis in a patient or diseased animal in need thereof, comprising administering a pharmaceutical composition comprising the same genus copolymer. This is not patentably distinct from the copending application’s claim 6, a method of treating fibrosis by administering this same genus polymer to a subject in need thereof, combined with claim 5, which already discloses formulating that polymer with a pharmaceutically acceptable carrier into an oral or parenteral dosage form.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/W.L./Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
