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 .
Status of the Claims
Claims 1-8 are pending.
Information Disclosure Statement
The IDS dated November 26, 2024 has been considered. A signed copy is enclosed herewith.
Claim Rejections - 35 USC § 103
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 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kuga et al. (“Polyallylamine-grafted cellulose gel as high-capacity anion-exchanger”, Journal of Chromatography A, 946, 2002, pp. 283-289; hereafter as “Kuga”) in view of Goldmann (US 2005/0002893 Al, Jan. 6, 2005; hereafter as “Goldmann).
The instant claims are drawn to a cationic copolymeric material comprising a protonated polysaccharide-polyamine copolymer having a three-dimensional structure, the polysaccharide-polyamine copolymer material comprising: selectively oxidized polysaccharide having a 2,3 di-aldehyde moiety; and amino polymers which provide a cationic amino functionality, the amino polymers covalently cross linking the oxidized polysaccharide to provide a particulate polysaccharide-polyamine copolymer and copolymeric material having an amino functionality which when protonated will provide the cationic copolymeric material with a nitrogen content of at least 12.5 wt.%, the cationic copolymer and cationic polymeric material being water insoluble.
Regarding instant claim 1, Kuga teaches a polysaccharide-polyamine copolymer having an amino functionality which will provide a protonatable copolymeric material having a three-dimensional structure with cationic sites through protonation comprising a selectively oxidized polysaccharide having a 2,3-dialdehyde moiety; and amino polymers which provide an amino functionality, the amino polymers crosslinking the oxidized polysaccharides to provide a particulate polysaccharide-polyamine copolymer having an amino functionality (pp. 284-286). Kuga discloses the column packed with the polyallylamine grafted cellulose gel has stability over months of chromatography operation utilizing various types of buffers (page 286, section 3.2), which is evidence of water insolubility. Kuga also teaches that the nitrogen/amino content was (page 284, section 2.3).
Kuga is also silent to a nitrogen content of at least 12.5%.
Goldmann is in the field of polysaccharide-polyamine copolymers (abstract; biocompatible components which can be chemically crosslinked together, in particular for gluing biological tissue, comprising at least the following components: a) aqueous solution of at least one polymer having amino groups b) aqueous solution of at least one aldehyde having at least three aldehyde groups) teaches the copolymeric material with a nitrogen content of at least 12.3 wt.% ([0046]; The content of polymer having amino groups of component a) is preferably from 1 to 25% by weight, in particular from 2 to 20% by weight).
Kuga and Goldmann are both drawn to polysaccharide-polyamine copolymers, thus, 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 optimize the amount of nitrogen in the copolymer of Kuga by way of routine experimentation, as suggested by Goldmann, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Goldmann teaches that modifying the amount of aldehyde groups and free amino groups directly effects the gelation and properties thereof (for the purpose of forming a stable gel ([0060] Mixing the two solutions results in formation of a gel which has adhesive properties. The gelation is based on the formation of imines (Schiff’s bases) between the aldehyde groups in the oxidized dextran and the free amino groups in the chitosan (see reaction scheme approach 1)).
Regarding instant claim 2, Kuga does not explicitly teach “wherein the amino polymers have a nitrogen content of at least 24.5 wt.%, based on the weight of the amino polymers and a molecular weight in the range of from about 15,000 to about 900,000.
However, Goldmann teaches wherein the amino polymers have a nitrogen content of at least 24.5 wt.%, based on the weight of the amino polymers and a molecular weight in the range of from about 15,000 to about 900,000” (Goldmann Para. [0046] The content of polymer having amino groups of component a) is preferably from 1 to 25% by weight, in particular from 2 to 20% by weight; Para. [0019] the polymer having amino groups is a synthetic polymer...The synthetic polymer is advantageously a modified polyvinyl alcohol having amino groups, preferably having a molecular weight of ≤50,000).
Kuga and Goldmann are both drawn to polysaccharide-polyamine copolymers, thus, 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 modify the copolymer of Kuga with the nitrogen content and molecular weight teaching of Goldmann with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Goldmann teaches that modifying the amount of aldehyde groups and free amino groups directly effects the gelation and properties thereof (for the purpose of forming a stable gel (Goldmann [0060] Mixing the two solutions results in formation of a gel which has adhesive properties. The gelation is based on the formation of imines (Schiff’s bases) between the aldehyde groups in the oxidized dextran and the free amino groups in the chitosan (see reaction scheme approach 1)).
Regarding instant claims 3, 6 and 7, Kuga teaches grafting of polyallylamine onto cellulose via dialdehyde groups (Pg. 285, 3.1.). Table 1 shows the aldehyde content of periodate-oxidized cellulose (DAC) and the amino group content of PAA-grafted cellulose (pg. 285). Kuga also teaches the periodate oxidation of cellulose can introduce aldehyde groups by cleaving the C2-C3 bond of glucopyranoside, resulting in the formation of two aldehyde groups per glucose unit (dialdehyde cellulose, DAC) (Pg. 283, Col. 2, Para. 2). Kuga further teaches that the DAC gel suspension (25-ml containing 1 g solid) was mixed with polyallylamine (Pg. 284, Col. 2, Para. 2, 2.3. Preparation of polyallylamine-cellulose gel).
Regarding instant claim 4, cellulose naturally contains β-1,4-glycosidic bonds as evidenced by Kilburn et al. (USPN 5,340,731; col. 7, lines 61-62).
Regarding instant claim 8, Kuga teaches porous cellulose particles as a starting material (pgs. 284-285). Kuga teaches an embodiment using a cellulose having a particle size of 53-125 microns which overlap with the claimed range. MPEP 2144.05 states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Because the claimed range of about 100 microns to about 100 mm overlaps with the range of 53-235 microns disclosed by the prior art, a prima facie case of obviousness exists.
Kuga is silent to the sizes of the pores of said porous cellulose particles, however the polysaccharide-polyamine copolymer of Kuga/Goldmann appears to be the same as the instantly claimed copolymer. MPEP 2112.01 states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ particles differ and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Thus, the combined teachings of Kuga and Goldmann render the instant claims prima facie obvious.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Kuga et al. (“Polyallylamine-grafted cellulose gel as high-capacity anion-exchanger”, Journal of Chromatography A, 946, 2002, pp. 283-289; hereafter as “Kuga”) in view of Goldmann (US 2005/0002893 Al, Jan. 6, 2005; hereafter as “Goldmann), as applied to claim 1 above, and further in view of Basu et al. (“Polysaccharide-Based Conjugates for Biomedical Applications”, Bioconjugate Chem. 2015, 26, 1396−1412; hereafter as “Basu”).
The claimed invention is described above.
Kuga teaches the elements discussed above.
Kuga is silent to the particular selectively oxidized polysaccharides, selectively oxidized dextran and selectively oxidized chitosan (instant claim 3) and wherein the selectively oxidized polysaccharides have β-1,6-glycosidic bonds (instant claim 5). It is noted that dextran contains β-1,6-glycosidic bonds ([0041] of instant specification).
Basu teaches polysaccharides contain different functional groups (such as hydroxyl, amino, carboxylic acid, aldehydes) that make them ideal for conjugation in biomedical applications (abstract). Basu teaches dextran, arabinogalactan, and cyclodextrin are commonly used polysaccharides for partial oxidization (section 2.4). Basu teaches that the 2,3-diols can be oxidized to dialdehydes using NaIO4 mediated, enzymatic, peroxide mediated oxidation (section 2.4). Figure 3 of Basu illustrates chemical modifications for partially oxidized polysaccharides including dextran and chitosan.
Kuga and Basu both teaches oxidizing polysaccharides, thus, 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 oxidized cellulose of Kuga for oxidized dextran or oxidized chitosan, as suggested by Basu, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Basu teaches that oxidized polysaccharides including oxidized dextran or oxidized chitosan provide dialdehyde functional groups capable of reacting or conjugating. Thus, the prior art effectively teaches that oxidized polysaccharides including oxidized cellulose, oxidized dextran, and oxidized chitosan are functional equivalents. See MPEP 2144.06(II).
Thus, the combined teachings of Kagu, Goldmann and Basu render the instant claims prima facie obvious.
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 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,639,325. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the patented claims are significantly overlapping.
The instant claims are drawn to a cationic copolymeric material comprising a protonated polysaccharide-polyamine copolymer having a three-dimensional structure, the polysaccharide-polyamine copolymer material comprising: selectively oxidized polysaccharide having a 2,3 di-aldehyde moiety; and amino polymers which provide a cationic amino functionality, the amino polymers covalently cross linking the oxidized polysaccharide to provide a particulate polysaccharide-polyamine copolymer and copolymeric material having an amino functionality which when protonated will provide the cationic copolymeric material with a nitrogen content of at least 12.5 wt.%, the cationic copolymer and cationic polymeric material being water insoluble.
The patented claims are drawn to pharmaceutical composition for treatments of hyperuricemia, the pharmaceutical composition comprises an amino-polysaccharide copolymer and a pharmaceutically acceptable salt thereof as an active ingredient, the amino-polysaccharide copolymer is a copolymerization product of the following two parts: a selectively oxidized polysaccharide having a 2,3-dialdehyde moiety, and an amino polymer which provides an amino functionality; the amino polymer cross linking the selectively oxidized polysaccharide having a 2,3-dialdehyde moiety to form a net-like structure and finally to provide a hydrogel having an amino functionality or a particulate amino-polysaccharide copolymer, amino functionalities of the hydrogel having an amino functionality or the particulate amino-polysaccharide copolymer can be protonated to form a cationic copolymer having three dimensional network structure and protonation sites, a nitrogen content of the cationic copolymer or the amino-polysaccharide copolymer is at least 12.3% weight percent, or at least 15% weight percent, or at least 22% weight percent, or at least 40% weight percent, the cationic copolymer and the amino-polysaccharide copolymer are both insoluble in water, wherein in the selectively oxidized polysaccharide having a 2,3-dialdehyde moiety, a ratio of an amount of oxidized glucose units to the total amount of glucose units is at least 50%, at least 70%, or at least 80%; and a method of using thereof. The patented claims further recite, “wherein a nitrogen content of the amino polymer which provides an amino functionality is at least 24.5% weight percent, or at least 30% weight percent, or at least 44% weight percent, or at least 80% weight percent”, “wherein a molecular weight of the amino polymer which provides an amino functionality is from about 15,000 to about 900,000”, “wherein the selectively oxidized polysaccharide having a 2,3-dialdehyde moiety is one or more selected from the group consisting of selectively oxidized cellulose, selectively oxidized amylopectin, and selectively oxidized chitosan”, “ wherein the selectively oxidized polysaccharide having a 2,3-dialdehyde moiety has at least one of a β-1,4-glycosidic bond or a β-1,6-glycosidic bond”, “wherein the amino polymer which provides an amino functionality is one or more selected from the group consisting of polyethyleneimine (PEI), poly(allylamine), polypropyleneimine (PPI), and polypropylenimine tetramine”, “the particulate amino-polysaccharide copolymer or the cationic copolymer is from 30 μm to 10 mm, or from 100 μm to 10 mm, or from 300 μm to 5 mm”, and “pores with diameters less than 50 μm, or has pores with diameters from 100 nm to 50 μm, or has pores with diameters from 200 nm to 40 μm, or has pores with diameters from 300 nm to 30 μm, or has pores with diameters from 400 nm to 20 μm, or has pores with diameters from 500 nm to 10 μm, or has pores with diameters from 800 nm to 5 μm”.
Thus, the subject matter of patented claims anticipates the subject matter of the instant claims and are, thereby, not patentably distinct from each other.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,925,893. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the patented claims are significantly overlapping.
The claimed invention is described above.
The patented invention is drawn to a method for the treatment of hypercholesterolemia, comprising: administering a pharmaceutical composition comprising an amino-polysaccharide copolymer or a pharmaceutically acceptable salt thereof as an active ingredient, wherein, the amino-polysaccharide copolymer is a copolymerization product of the following two parts: a selectively oxidized polysaccharide having a 2,3-dialdehyde moiety, and an amino polymer which provides an amino functionality, wherein the selectively oxidized polysaccharide is one or more selected from the group consisting of selectively oxidized cellulose, selectively oxidized amylopectin, and selectively oxidized chitosan and wherein the amino polymer is at least one selected from the group consisting of polyethyleneimine (PEI) and poly(allylamine) (PLA), and the amino polymer cross linking the selectively oxidized polysaccharide having a 2,3-dialdehyde moiety to form a net-like structure and finally to provide a hydrogel having an amino functionality and a particulate amino-polysaccharide copolymer, wherein a carbon nitrogen double bond resulted from the crosslinking is reduced to a single bond; amino functionalities of the hydrogel having an amino functionality and the particulate amino-polysaccharide copolymer can be protonated to form a cationic copolymer having three dimensional network structure and protonation sites, wherein a nitrogen content of the cationic copolymer or the amino-polysaccharide copolymer is at least 12.3% weight percent, or at least 15% weight percent, or at least 22% weight percent, or at least 40% weight percent, and the cationic copolymer and the amino-polysaccharide copolymer are both insoluble in water, and wherein in the selectively oxidized polysaccharide having a 2,3-dialdehyde moiety, a ratio of an amount of oxidized glucose units to the total amount of glucose units is at least 50%, or at least 70%, or at least 80%. The patented claims further recite, “wherein a nitrogen content of the amino polymer which provides an amino functionality is at least 24.5% weight percent, or at least 30% weight percent, or at least 44% weight percent, or at least 80% weight percent”, “wherein a molecular weight of the amino polymer which provides an amino functionality is from about 15,000 to about 900,000”, “wherein the selectively oxidized polysaccharide having a 2,3-dialdehyde moiety has at least one of a β-1,4-glycosidic bond or a β-1,6-glycosidic bond”, particles sizes from 30 μm to 10 mm, or from 100 μm to 10 mm, or from 300 μm to 5 mm, and pores with diameters of less than 50 μm, or pore diameters from 100 nm to 50 μm, or pore diameters from 200 nm to 40 μm, or pore diameters from 300 nm to 30 μm, or pore diameters from 400 nm to 20 μm, or pore diameters from 500 nm to 10 μm, or pore diameters from 800 nm to 5 μm.
Thus, the subject matter of patented claims anticipates the subject matter of the instant claims and are, thereby, not patentably distinct from each other.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,723,809. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the patented claims are significantly overlapping.
The claimed invention is described above.
The patented invention is drawn to a polysaccharide-polyamine copolymer or glycoprotein-polyamine copolymers having an amino functionality which will provide a cationic copolymeric material having a three-dimensional structure with cationic sites when protonated, the polysaccharide-polyamine copolymer comprising: a selectively oxidized polysaccharide or selectively oxidized glycoproteins, both the selectively oxidized polysaccharide and the selectively oxidized glycoproteins having a 2,3-dialdehyde moiety; and amino polymers which provide an amino functionality, the amino polymers cross-linking the oxidized polysaccharides to provide a particulate polysaccharide-polyamine copolymer or glycoprotein-polyamine copolymers having an amino functionality, the polysaccharide-polyamine copolymer or the glycoprotein-polyamine copolymers having a pore size configured to support cells on an interior surface, wherein the amino polymers have a nitrogen content of at least 0.5% and no more than 30 wt. %, based on the weight of the amino polymers, and wherein the amino polymers have a molecular weight in the range of from about 15,000 to about 900,000; and a method of making thereof. The patented claims further recite, “wherein the selectively oxidized polysaccharide is selected from the group consisting of selectively oxidized cellulose, selectively oxidized starch, selectively oxidized amylose, selectively oxidized chitosan, selectively oxidized dextran, selectively oxidized glycogen, selectively oxidized chitin, polysaccharide side chain of mucin, and mixtures thereof, the polysaccharide having been oxidized in an amount effective to provide a 2,3-dialdehyde moiety which is reactive with the amino polymers”, “wherein the amino polymers are selected from the group consisting of polyethyleneimine, poly(allylamine) and polypropylenimine tetramine, protein, polypeptides, and mixtures thereof”, “wherein the selectively oxidized polysaccharide have β-1,4-glycosidic bonds or β-1,6-glycosidic bonds”, and particle sizes in the range of from about 100 μm to about 10 mm.
While the patent recites a nitrogen content of at least 0.5% and no more than 30 wt. %, the patent does not explicitly recite a nitrogen content of at least 12.5 wt%.
MPEP 2144.05 states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”.
Because the claimed range of at least 12.5 wt% overlaps with the range of the patent, i.e., at least 0.5% and no more than 30 wt. %, a prima facie case of obviousness exists.
Thus, the subject matter of patented claims and the subject matter of the instant claims are not patentably distinct from each other.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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