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 .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on June 26, 2026 has been entered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Status of Claims
Claims 1, 4, 6, 7, 9-18 and 20 are currently pending in the instant application. Claim 1 has been amended by Applicants’ amendment filed 06-26-2026. No claims have been added or canceled by Applicants’ amendment filed 06-26-2026.
Applicant's election of Group I, claims 1-10 and 12, directed to a protein-binding product; and a device containing said protein-binding product according to claim 1, in the reply filed October 18, 2023 was previously acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election of invention has been treated as an election without traverse (MPEP
§ 818.03(a)).
Claims 11 and 13-16 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
The restriction requirement was previously deemed proper and was made FINAL.
Therefore, claims 1, 4, 6, 7, 9, 10, 12, 17, 18 and 20 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed September 8, 2020 is a 35 U.S.C. 371 national stage filing of International Application No. PCT/SE2019/050211, filed on March 8, 2019, which claims the benefit of Swedish Patent Application SE1800056-2, filed March 8, 2018.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Sweden on March 8, 2018; and filed September 8, 2020.
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 the first paragraph of 35 U.S.C. 112. 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 SE1800056-2, filed September 8, 2020, fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. The specific method steps recited in independent claim 1 does not have support for; “one or more porous polymer beads via an aliphatic or aromatic spacer in a range of 0.1-20 mmol per mL polymer”. Thus, the priority date for the presently claimed invention is March 8, 2019, the filing date of the claims is the filing date of PCT/SE2019/050211.
Applicants are invited to specifically indicate the location of the cited phrase pertinent to claim 1 of the instant application.
Withdrawn Objections/Rejections
Applicants’ amendment and arguments filed June 26, 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
Maintained Objections/Rejections
Claim Interpretation: the term “a D-galactosyl group or GalNAc group” as recited in claim 1 is interpreted to refer to a D-Gal or a GalNAc with a glycosidic bond that is a or b.
The term “that binds an antibody…or human blood plasma toxin” as recited in claim 17 is interpreted to refer to a capability of the carbohydrate or carbohydrate derivative compound (e.g., it does not refer to a carbohydrate or carbohydrate derivative compound that is bound to an antibody, etc.).
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1, 4, 6, 7, 9, 10, 12, 17, 18 and 20 is maintained under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 1, 6, 7 and 18 are indefinite for the recitation of the terms “in a range of 0.1-20 mmol per mL polymer”; “in a range of 0.1-5 mmol per mL polymer”; and “in a range of 5-20 mmol per mL polymer” such as recited in claim 1, lines 3-4 because it is unclear what the terms refer to since claim 1 is directed to a product, no polymer is recited, and no polymer is recited to be dissolved in a solution. It is unclear whether the terms refer to the concentration range of a disaccharide ligand, whether the terms refer to the concentration of one or more porous polymer beads, to the disaccharide derivatives, to the aliphatic or aromatic spacer, and/or whether the terms refer to something else. Additionally, it is unclear how any concentration range is applicable in the instant claims because claim 1 does not recite the presence of any solution, solvent, biological fluid, etc. that can produce the recited concentration range (e.g., per milliliter of what ?) and, thus, the metes and bounds of the claim cannot be determined.
Claims 1, 6, 7 and 18 are indefinite for the recitation of the term “polymer” such as recited in claim 1, line 4. There is insufficient antecedent basis for the term “polymer” in the claims because claim 1, line 1 recites the term “one or more porous polymer beads”. The Examiner suggests that Applicant amend the claim to recite, for example, “the one or more porous polymer beads comprising a polymer.”
Claim 1 is indefinite for the recitation of the term “a substituent at the 3-OH group of Gal” such as recited in claim 1, line 7 because it is unclear which 3-OH group(s) of Gal are substituted in Galb1-3GalNAcb-O; and whether all of substituents (a)-(d) are substituents at a single 3-OH group of Galb1-3GalNAcb-O, and/or whether both of the 3-OH groups of Galb1-3GalNAcb-O can be substituted with substituents (a)-(d) and, thus, the metes and bounds of the claim cannot be determined.
Claim 1 is indefinite for the recitation of the term “when said disaccharide ligand is Galb1-4GlcNAcb-O- derivative, the substituent is one of groups a)-d) except when the R2 group is a D-galactosyl group selection b) is excluded” such as recited in claim 1, lines 17-18 because it is unclear how b) is excluded based on b). For example, b) recites that 3-OR2 group contains a D-galactosyl group or a GalNAc group, such that the term reads on itself (e.g., when R2 is a D-galactosyl group, then selection b) is excluded, but b) is when R2 is a D-galactosyl group) and, thus, the metes and bounds of the claim cannot be determined.
Claim 1 is indefinite for the recitation of the term “the R2 group” such as recited in claim 1, lines 11-13 and 18. There is insufficient antecedent basis for the term “the R2 group” in the claim because claim 1, line 11 recites the term “a 3-OR2 group”.
Claim 1 is indefinite for the recitation of the term “the groups a)-d)” such as recited in claim 1, lines 16 and 18. There is insufficient antecedent basis for the term “the groups a)-d)” in the claim because claim 1, lines 11-14 recites the terms a), b), c) and d).
Claim 1 is indefinite for the recitation of the term “selection b)” such as recited in claim 1, line 18. There is insufficient antecedent basis for the term “selection b)” in the claim because claim 1, lines 11-14 recites the terms a), b), c) and d).
Claim 6 is indefinite for the recitation of the term “wherein the disaccharide ligand is in a range of 0.1-20 mmol per mL polymer” such as recited in claim 6, lines 1-2 because claim 6 depends from instant claim 1, and claim 6 is essentially a duplicate of instant claim 1 and, thus, the metes and bounds of the claim cannot be determined
Claim 17 is indefinite for the recitation of the term “a covalently bound carbohydrate or carbohydrate derivative” in claim 17, lines 2-3 because claim 17 depends from instant claim 1, wherein claim 1 does not recite a carbohydrate that is not a 3-OH derivative or any “carbohydrate derivative compounds”. Thus, it is unclear whether the term “carbohydrate derivative compounds” is intended to refer to the disaccharide ligand derivatives as encompassed by claim 1(a)-(d); or whether the term refers to an additional carbohydrate or carbohydrate derivative bound to each of the one or more porous polymer beads and, thus, the metes and bounds of the claim cannot be determined.
Claim 20 is indefinite for the recitation of the term “the ligand” such as recited in claim 20, lines 1-2. There is insufficient antecedent basis for the term “the ligand” in the claim because claim 1, line 2 recites the term “a disaccharide ligand”. Moreover, claim 20 depends from instant claims 1 and 17, wherein claim 17 recites very specific blood group A and blood group B antigens, such that claim 20 is broader than claim 17 and, thus, the metes and bounds of the claim cannot be determined.
Claims 4, 9, 10 and 12 are indefinite insofar as they ultimately depend from instant claim 1.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 6, 7, 9, 10, 12, 17, 18 and 20 is maintained under 35 U.S.C. 102(a1)/102(a2) as being anticipated by Nilsson et. al. (hereinafter “Nilsson”) (US Patent Application Publication No. 20040022784, published February 5, 2004; of record) as evidenced by Nilsson et. al. (hereinafter “Nilsson ‘230”) (US Patent Application Publication No. 2020406230, published December 31, 2020; of record).
Regarding claims 1, 17 and 20, Nilsson teaches material characterized by that the material contains at least one biologically active saccharide which is covalently bound via at least one spacer to a cross-linked matrix and that the material is autoclaved (interpreted as a disaccharide covalently bound; and a spacer, claim 1) (Abstract). Nilsson teaches that a saccharide can consist of a glycoprotein, a neoglycoprotein, a glycopeptide or a glycosylated amino acid, a glycolipid, or a part, a fragment or a modified variant thereof, or another biologically active disaccharide or trisaccharide or higher oligosaccharide substance (interpreted as a disaccharide, claim 1) (paragraph [0005]). Nilsson teaches that the material consists, as a non-limiting example, of for example either: Blood group A-O(CH2)n-PhNH-CO(CH2)mNH-CH2-CH(OH)-CH2-O-Matrix or: Blood group B-O(CH2)nPhNH-CO-(CH2)mNH-CH2-CH(OH)-CH2-O-Matix, wherein “Matrix” denotes a plastic or a polysaccharide, such as a cross-linked agarose or Sepharose Fast Flow; -O(CH2)n-PhNH-CO(CH2)mNH-CH2-CH(OH)-CH2-O- is a spacer; n is an integer from 0 to 4; and m is an integer from 0 to 7 (interpreted as a aliphatic and/or aromatic spacer; and bloods groups A and B (interpreted as bound to a matrix that binds a blood group A specific antibody, and blood group B-specific antibody; and porous polymer beads, claims 1 and 17) (paragraphs [0008]-[0011]). Nilsson teaches that instead of the -O(CH2)2PhNH- group in the formulas supra, another suitable Spacer or part of Spacer can be used including -O-(CH2)nNH- or another aliphatic compound, or another aromatic compound (interpreted as an aliphatic or aromatic spacer; and the spacers recited in claim 9, claims 1 and 9) (paragraph [0021]). Nilsson teaches that the saccharide, for example the blood group A- or B-determinant, can also be bound, directly or indirectly, to an oligomeric substance acting as spacer, or part of spacer, as for example a monosaccharide, disaccharide, or higher oligosaccharide or polysaccharide, peptide, for example a peptide consisting of amide bound glycine and glutamic acid residues, for example Gly-(Glu-Gly)n-Glu, where n is an integer between for example 1 and 20, wherein the saccharide-spacer consists of 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 or more saccharide units bound to each oligomeric substance or peptide (interpreted as encompassing disaccharides; and carbohydrates, carbohydrate derivatives compounds or ligands that bind to blood group A or B specific antibodies, claims 1 and 17) (paragraph [0022]). Nilsson teach that an advantage of using oligomeric ligands is that antibodies towards blood group determinant or other proteins, viruses or cells can be separated to obtain a more efficient product compared with non-oligomeric ligand (interpreted as ligands that bind to blood group A or B specific antibodies; and A or B antigen, claims 1, 17 and 20) (paragraph [0026]). Nilsson teaches an aliphatic or aromatic spacer be used to bind the saccharide to the lysine residues of the peptide, but in this case is, for example, glycosidically bound groups of the type -O(CH2)2PhCOO-, or for example O(CH2)nCOO-, used for carbodiimide- or succinimide-mediated coupling between saccharide and lysine residues in the peptide (interpreted as aliphatic and aromatic spacers, claim 1) (paragraph [0030]). Nilsson teaches that the saccharide can then first be coupled to the protein, or to the polysaccharide, which then is coupled to the Matrix (interpreted as polymer beads that bind galactose-binding proteins, claim 1) (paragraph [0032]). Nilsson teaches that the products can be used for specific removal of proteins in connection with blood plasma separation, for example antibodies directed towards Gala1-3Gal and other so called xeno antigens in connection with xeno-transplantation (interpreted as binding human blood plasma toxins, claim 19) (paragraph [0034]). Nilsson teaches that the product according to the invention can be used with commercially available activated matrix such as NHS-activated Sepharose 4 Fast Flow, which is present in the form of practically spherical particles (interpreted as porous polymer beads comprising the disaccharide ligands of the invention as beads that bind galectins, claims 1, 4 and 12) (paragraph [0038], lines 1-7), where it is known that galectins are a class of proteins that bind specifically to b-galactoside sugars; and that the compounds of the invention can be used to quantitatively reduce the level of galectin including galectin-1, galectin-3 and galectin-8 in human blood plasma as evidenced by Nilsson ‘230 (paragraph [0002]; [0034]; and [0036], lines 1-3). Nilsson teaches Gala1-3Galb1-4GlcNAcb-; (Gala1-3Galb1-4GlcNAcb-)n-; (Gala1-3Galb1-4GlcNAcb-spacer)n- and Gal ≠ 1-3Galb1-4GlcNAcb-spacer)n-, wherein n is an integer larger than 1 (interpreted as polymer beads comprising a disaccharide ligand including Galb1-4GlcNAcb-O- and Galb1-3GlcNAcb-O- wherein R2 is a D-galactosyl (Gala) group attached at the 3-OH group of Gal; bound to a spacer; and to the surface of at least one porous polymer bead, claim 1) (paragraphs [0043]-[0044]). Nilsson teaches that other carbohydrate structures active towards other antibodies such as antibodies against cancer-antigens including breast-, prostate-, intestine-, or skin cancer can be used to form Product according to the invention (interpreted as other carbohydrate structures that bind to antibodies including receptor antibodies; interpreting cancer as a human blood plasma toxin; and A or B antigen, claims 1, 17 and 20) (paragraph [0045]). Nilsson teaches that non-limiting examples of bound amount of saccharide is 0.01, 0.1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 mmole of ligand per liter of Matrix (interpreted as 0.1-20 mmol/mL polymer, claims 1, 7, and 18) (paragraph [0024], lines 15-20). Nilsson teaches a column volume of 10 mL, 20 mL, 40 mL, 60 mL up to, for example, 500 ml, and using a matrix particle size in the interval of 40-200 micrometer (interpreted as encompassing 0.1-20 mmol/mL polymer, claims 1, 6, 7 and 18) (paragraphs [0048]-[0049]). It is noted that MPEP 2144.05(II)(A) states that: “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In the instant case, a concentration range and/or the effectiveness of protein-binding can be affected by the size and identity of the porous polymer beads; the specific disaccharide derivatives attached to each bead; the size of the bead pores; the number of ligands per bead; the identity of the spacer; the method of use; the analyte to be bound; the size of the column; whether pressure is applied; the amount of biological sample; the solvent or solution used; the identity of the matrix; the specific protein or mixture of proteins to be bound; the amount and/or concentration of target proteins in the blood/plasma, etc.
Regarding claim 4, Nilsson teaches that the product according to the invention can be used with commercially available activated matrix such as NHS-activated Sepharose 4 Fast Flow, which is present in the form of practically spherical particles (interpreted as porous polymer beads comprising the disaccharide ligands of the invention as beads that bind galectins, claims 1, 4 and 12), where it is known that galectins are a class of proteins that bind specifically to b-galactoside sugars; and that the compounds of the invention can be used to quantitatively reduce the level of galectin including galectin-1, galectin-3 and galectin-8 in human blood plasma as evidenced by Nilsson ‘230 (paragraph [0002]; [0034]; and [0036], lines 1-3).
Regarding claims 6, 7 and 12, Nilsson teaches that the product according to the invention can be used with commercially available activated matrix such as NHS-activated Sepharose 4 Fast Flow, which is present in the form of practically spherical particles (interpreted as porous polymer beads comprising the disaccharide ligands of the invention, claims 1, 4 and 12) (paragraph [0038], lines 1-7). Nilsson teaches that the product according to the invention can use so-called epoxyactivated Sepharose 4 Fast Flow, to which is covalently bound, for example Blood group A-O(CH2)nPhNH-CO(CH2)mNH-, or to which is covalently bound Blood group B--O(CH2)nPhNH-CO--(CH2)mNH- (interpreted as porous polymer beads comprising the disaccharide ligands of the invention, claims 1, 4 and 12) (paragraph [0039]). Nilsson teaches a single passage of more than one liter blood group B plasma with a flow rate of about 40 ml/minute through a column with about 3 micromole of blood group A trisaccharide per ml Sepharose 4 FF, wherein a total product volume of 62 ml and a particle size of 90 microns practically eliminated all antibodies reactive against blood group A and blood group B (interpreted as a column containing the binding product of claim 1; and 3 mm saccharide per ml polymer, claims 6, 7 and 12) (paragraph [0047], lines 6-13). Nilsson teaches that non-limiting examples of bound amount of saccharide ligand is 0.01, 0.1, 1, 2, 3, 4, 5, 6, 7…19, 20 mmole of ligand per liter of Matrix (interpreted as 0.1-20 mmol/mL polymer, claims 1, 7, and 18) (paragraphs [0012]; and [0024], lines 15-19).
Regarding claim 9, Nilsson teaches that instead of the -O(CH2)2PhNH- group in the formulas supra, another suitable Spacer or part of Spacer can be used including -O-(CH2)nNH- or another aliphatic compound, or another aromatic compound (interpreted as an aliphatic or aromatic spacer; and the spacers recited in claim 9, claims 1 and 9) (paragraph [0021]). Nilsson teaches that the activated Matrix can be used for covalent binding of Blood group A-O (CH2)nPhNH2- to give product 1a, and Blood group B--(CH2)nPhNH2- to give product 2b (interpreted as a spacer of claim 9, claim 9) (paragraph [0038], lines 8-12).
Regarding claim 10, Nilsson teaches that the Matrix denotes a plastic or a polysaccharide, for example cross-linked agarose, specifically of the type Sepharose Fast Flow (interpreted as agarose and cross-linked agarose beads, claim 10) (paragraph [0010]).
Regarding claim 18, Nilsson teaches that the saccharide-spacer can be added to the reaction mixture in a desired molar excess in relation to the amount of moles of peptide, wherein the molar excess can be 2, 3, 4, 5, 6, 7, 8, 9, or 10 times excess or more; and other reaction conditions are chosen by the expert and do not limit the scope of the invention, wherein Saccharide is 0.01, 0.1, 1, 2, 3, 4, 5, 10, 15, 20 mmole of ligand per liter of matrix (interpreted as encompassing 5-20 mm per ml of polymer, claim 10) (paragraph [0024], lines 9-19).
Nilsson meets all the limitations of the claims and, therefore, anticipates the claimed invention.
Response to Arguments
Applicant’s remarks filed June 26, 2026 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) claim 1 now recites a range of 0.1-20 μmol per mL polymer", where the polymer references the porous polymer beads component of the protein-binding product, which is not readily apparent in the Nilsson reference (Applicant Remarks, pg. 7, fourth and fifth full paragraphs); and (b) the adventitious product was not recognized (Applicant Remarks, pg. 7, fifth full paragraph, line 4);
Regarding (a), although the claims are interpreted in light of the specification, limitations from the Specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26USPQ2d 1057 (Fed. Cir. 1993). Moreover, as noted in MPEP 2112.01(I),
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).
Applicant’s assertion that Nilsson does not teach the concentration range of 0.1-20 μmol per mL polymer, where the polymer references the porous polymer beads component of the protein-binding product, which is not readily apparent in the Nilsson reference, is not found persuasive. As an initial matter, please see the discussion supra regarding the 35 USC 112(b) rejection, wherein the term is unclear. Instant claim 1 is directed to a product, such that claim 1 is not directed to a method of making or using the product. Moreover, instant claim 1 does not recite the presence of a polymer, such that it is completely unclear what the concentration range refers to. Additionally, it is unclear how any concentration range is produced in instant claim 1 because claim 1 does not recite any solution, solvent, biological fluid, matrix, etc. that would form a concentration. The polymer, how the polymer relates to the product as recited in claim 1, and/or how a concentration is produced without a solvent or solution is completely unclear. Furthermore, the Examiner contends that Nilsson teaches the claimed concentration range. To that end -
Nilsson teaches:
A non-limiting examples of bound amount of saccharide ligand is 0.01, 0.1, 1, 2, 3, 4, 5, 6…20 mmole per liter of Matrix (interpreted as encompassing a concentration range of 0.1-20 mmol/mL polymer, claims 1, 7, and 18) (paragraphs [0012]; and [0024], lines 15-19).
A column volume of 10 mL, 20 mL, 40 mL, 60 mL up to, for example, 500 ml, and using a matrix particle size in the interval of 40-200 micrometer (interpreted as encompassing a concentration range of 0.1-20 mmol/mL polymer, claims 1, 6, 7 and 18) (paragraphs [0048]-[0049]).
Nilsson teaches all of the limitations of the claims. Thus, the claim remains rejected.
Regarding (b), please see the discussion supra regarding the Examiner’s response to Applicant’s argument. Applicant’s assertion that the adventitious product was not recognized, is not found persuasive. As an initial matter, the term “adventitious” is defined as something that happens by chance rather than by design as evidenced by the Oxford English Dictionary (pg. 1, first full paragraph). As noted in MPEP 2112.01(II):
"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty") (underline added).
Nilsson teaches all of the limitations of the claims including the structures of the saccharide derivatives encompassed by the limitations as recited in claim 1. Thus, the derivatives taught by Nilsson have the same properties as the protein-binding product recited in instant claim 1. Moreover, MPEP § 2112(I) states:
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that, "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103.
Additionally, Applicant has not shown that the specific modifications and/or the improvements in properties were unknown in the prior art including the ability of the disaccharide derivatives to bind galectins. Thus, the claims remain rejected.
Claim Rejections - 35 USC § 103
The rejection of claims 1, 4, 6, 7, 9, 10, 12, 17, 18 and 20 is maintained under 35 U.S.C. 103 as being unpatentable over Nilsson et. al. (hereinafter “Nilsson”) (US Patent Application Publication No. 20040022784, published February 5, 2004; of record) in view of Iwaki et al. (hereinafter “Iwaki”) (Trends in Glycoscience and Glycotechnology, 2018, 30(172), SE137-SE153; and Supplementary Material, 2018, 30(172), 1-7; of record) as evidenced by Nilsson et. al. (hereinafter “Nilsson ‘230”) (US Patent Application Publication No. 20200406230, published December 31, 2020; of record).
The teachings of Nilsson as applied to claims 1, 4, 6, 7, 9, 10, 12, 17, 18 and 20 are described supra.
Nilsson does not specifically teach the term galectin (claim 4, in part).
Regarding claim 4 (in part), Iwaki teaches in Figure 1, a diagram of the Fontal Affinity Chromatograph (FAC) apparatus is shown, wherein the advantages of FAC-FD are summarized in Table 2 including wherein FAC analysis accurate concentration of analyte is not necessarily known if it is negligibly small compared to Kd; and that current FAC using PA oligo-saccharides has a few drawbacks, wherein reduced terminal monosaccharides take an open structure as a result of monoamine coupling (Figure 2), such that this is common to other methods using the same chemical procedure, e.g., 2-AA, 2-AB, ethyl p-aminobenzoate, 2-aminoacridone, and 8-aminopyrene-1,3,6-trisulfonic acid; as well as, the necessity to immobilize ligands (lectins), which can modify or reduce lectin functions, where some lectins are inactivated upon immobilization (pg. 140, col 2, first full paragraph, and last partial paragraph). Iwaki teaches that the features of galectin specificity has been demonstrated by preceding works by a Hakon Leffler's group, where they found the basic galectin-binding "epitopes" on disaccharides; and demonstrated what additions prevent binding and what additions enhance binding for some galectins, wherein these epitopes consist of three hydroxyl groups of the recognition disaccharides like lactose (Galb1-4Glc) and LacNAc (Galb1-4GlcNAc); namely C4-OH and C6-OH of non-reducing terminal Gal and C3-OH of reducing terminal Glc/GlcNAc; as well as, finding that Galb1-3Glc can be a ligand for galectins, though the affinity is considerably lower when compared with its isomer, LacNAc both in galectin-1 and galectin-3 (interpreted as lactose, LacNAc, and Galb1-3Glc as being able to bind galectins, claims 3and 4) (pg. 142, col 1, first partial paragraph). Iwaki teaches in Figure 2, a reaction scheme of monoamine coupling between a reducing sugar and a coupling agent, wherein after the coupling reaction, the derived Schiff base is reacted with NaBH2CN to stabilize the chemical structure (interpreted as a derivative, claim 1) (pg.142, Figure 2). Figure 2 is shown below:
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Iwaki teaches that based on the configuration of the glycosidic linkages regarding the reducing terminal monosaccharides are further categorized into two cases of configuration pattern: one is the "typical'' pattern comprising Galb1-4Glc (lactose), Galb1-4GlcNAc (LacNAc), GalNAcb1-4GlcNAc (LeadiNAc), GalNAcb1-4GlcA (chondroitin component), Galb1-4Man (Leishmania epitope), and Galb1-3GlcNAc (lacto-N-biose), where the equatorial 3-OH or 4-OH of the reducing terminal mono-saccharides form a hydrogen bond network with the commonly conserved Glu and Arg residues located on S6 (interpreted as the products of claim 1 that bind galectins, claims 1, 3 and 4) (pg. 142, col 2; last partial paragraph, lines 7-16). Iwaki teaches that the other configuration is the ''atypical” pattern comprising GalNAcb 1-3Gal (non-reducing terminal disaccharide in globotetraose, Gb4) and Galb1-3GalNAc (T antigen and non-reducing terminal disaccharide, GA1 ), wherein these disaccharides have been reported as galectin ligands, while the affinities for the isolated glycans were relatively low in comparison with LacNAc, where galectin-1 and galectin-3 can bind to Galb1-3GalNAc (interpreted as the products of claim 1 that bind galectins, claims 1, 3 and 4) (pg. 142, col 2; last partial paragraph, lines 16-18; and pg. 145, col 1; first partial paragraph, lines 1-4). Iwaki teaches that a variety of galectin binding to 3’-modified b-galactosides is described, wherein most galectins accommodate substitutions at this position some of them showing an enhanced affinity to the resultant saccharides unlike other galactose-binding lectins, such as R-type lectins, legume lectins, and C-type lectins, which require 3-OH group of Gal for recognition (interpreted as 3-OH group of Gal for galectin recognition; and 3’ Gal derivatives as encompassed by claim 1, claims 1 and 4) (pg. 145, col 2, first full paragraph). Iwaki teaches 3’-sualyated and 3’-sulfated lactose (pg. 145, col 2, last partial paragraph; pg. 146, col 1, first partial paragraph; and Figure 5). Iwaki teaches that chondroitin/dermatan sulfate composed of GalNAcb1-4GlcA/IdoA, selectively interacts with galectin-3, 7, 9N, and 9C (interpreted as binding galectins, claims 1 and 4) (pg. 148, col 1; last full paragraph, lines 5-6). Iwaki teaches that the two patterns (typical and atypical) are common in that the non-reducing terminal galactose is linked to a penultimate residue with a glycosidic bond to an equatorial hydroxyl group such as C3/4-OH of Glc(NAc)/GlcA/Man in typical and C3-OH of Gal(NAc) in atypical cases (pg. 145, col 1; first partial paragraph, lines 18-22). Iwaki teaches that thus far, only short O-linked glycans are available as four p-nitrophenyl derivatives of which three showed significant binding to galectins, while core 6 did not because it is not compatible with the Galb-equatorial manner (interpreted as 3-OR2 group, where R2 is an aromatic group; and binding to galectins, claims 1, 3 and 4) (pg. 150, col 1; first partial paragraph, lines 1-3). Iwaki teaches the development of galectin inhibitors, wherein T-cell activation is exquisitely modulated by tight association of galectin-3 with branched and extended N-glycans on T-cell receptor complex, wherein galectin-3 regulates plasma cell differentiation from peritoneal B1 cells, and regulates the acceleration of cancer malignancy; while galectin-1 promotes plasma cell differentiation from activated mature B cells and immunoglobulin production; and galectin-8 specifically binds to CD44 and is mediated by specific glycan recognition, while inhibition causes activation of inflammatory cells, resulting in inhibition of apoptosis of autoimmune inflammation in rheumatoid arthritis (pg 150, col 1, last partial paragraph; and col 2, first partial paragraph). Iwaki teaches elution profiles of pNP-glycan, which is diluted to appropriate concentrations (approximate 5.0-100μM), compared with a control glycan (e.g., pNP-bMan) (interpreted as encompassing a range of 0.1-20 mM, claims 1, 6, 7 and 18) (Figure 1).
It is prima facie obvious to combine prior art elements according to known methods to yield predictable results; the court held that, "…a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950)”. Therefore, in view of the benefits of analyzing lectin-glycan interactions as exemplified by Iwaki, it would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of characterizing biologically active saccharides by covalently binding saccharides including Gala1-3Galb1-4GlcNAcb and Gala1-3Galb1-4GlcNAcb to at least one spacer, which binds a cross-linked matrix as disclosed by Nilsson to include different 3’ saccharide modifications such as on Galb1-4Glc, Galb1-4GlcNAc, GalNAcb1-4GlcNAc, GalNAcb1-4GlcA, Galb1-4Man, and Galb1-3GlcNAc including at equatorial Gal 3-OH or 4-OH as taught by Iwaki, with a reasonable expectation of success in evaluating modified and/or substituted di-saccharides and/or tri-saccharides for selective galectin binding activity, galectin inhibition and/or for antibody binding properties including for the removal of specific antibodies or proteins from blood, for blood-plasma separation, and/or for the treatment of disease such as cancer and immunological disorders.
Thus, in view of the foregoing, the claimed invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, the claims are properly rejected under 35 USC §103 as obvious over the art.
Response to Arguments
Applicant’s remarks filed June 26, 2026 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) the criticality of the ligand/polymer ratio in achieving the disclosed properties of the protein-binding product is not, such that the claimed Nilsson product represents an improvement over the earlier product. Iwaki does teach as the Examiner states. However, more detail is needed. There is no reasonable expectation of success; and the role of each claimed component is not recognized including the range of 0.1-20 μmol per mL polymer (Applicant Remarks, pg. 8, entire page).
Regarding (a), it is noted that none of the references has to teach each and every claim limitation. If they did, this would have been anticipation and not an obviousness-type rejection. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145 also states:
Rebuttal evidence may also include evidence that the claimed invention yields unexpectedly improved properties or properties not present in the prior art. Rebuttal evidence may consist of a showing that the claimed compound possesses unexpected properties. Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1901. A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997) (underline and italics added).
Additionally, the evidence must be reasonably commensurate in scope with the claimed invention. See, e.g., In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990); In re Grasselli, 713 F.2d 731, 743, 218 USPQ 769, 777 (Fed. Cir. 1983) (underline and italics added).
In order for evidence of secondary considerations to be accorded substantial weight, there must be a nexus, i.e., a legally and factually sufficient connection or correspondence between the submitted evidence and the claimed invention. Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373, 2019 USPQ2d 483355 (Fed. Cir. 2019), cert. denied, 141 S.Ct. 373 (2020). See MPEP § 716.01(b) (underline and italics added).
MPEP 2112.01(II) indicates:
"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (underline added).
Please see the discussion supra regarding the Examiner’s response to Applicant’s arguments including the teachings of the combination of Nilsson and Iwaki. Applicant’s assertion that the criticality of the ligand/polymer ratio in achieving the disclosed properties of the protein-binding product is not, such that the claimed Nilsson product represents an improvement over the earlier product; and there is no reasonable expectation of success; and the role of each claimed component is not recognized including the range of 0.1-20 μmol per mL polymer, is not found persuasive. Additionally,
Iwaki teaches:
Elution profiles of pNP-glycan, which is diluted to appropriate concentrations (approximate 5.0-100μM), compared with a control glycan (e.g., pNP-bMan) (interpreted as encompassing 0.1-20 mM/mL polymer, claim 1) (Figure 1).
Moreover, MPEP 2144.05(II)(A) states that: “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In the instant case, a concentration range can be affected by the size and identity of the porous polymer beads; the specific disaccharide derivative attached to the beads; the size of the bead pores; the number of ligands per bead; the identity of the spacer; the method of use; the analyte to be removed; the size of the column; whether pressure is applied; the amount of biological sample; the solvent or solution used; the matrix; the specific protein or mixture of proteins to be bound; the amount and/or concentration of blood/plasma, etc. The Examiner contends that:
The claims are directed to a protein-binding product; however, claim 1 does not recite the binding of proteins to the product.
Instant claim 1 does not identify the polymer present in the recited concentration range; and claim 1 does not recite any solution, solvent and/or biological fluid that generates the concentration of the unidentified polymer of claim 1.
No properties of the protein-binding product and/or the criticality of the ligand/polymer ratio in achieving any unidentified properties is recited in instant claim 1.
Applicant has not specifically identified the “earlier product” to which Applicant is comparing the instant invention. Applicant has not provided any proof that the instant invention provides specific asserted improvements over said earlier product.
The “critical” concentration range is clearly taught by the combined references of Nilsson and Iwaki. Additionally, the Examiner believes that the invention would be equally effective at other concentration ranges as well.
As noted stated in the MPEP - generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
Instant claim 1 does not recite any role for each claimed component, ligand, derivative, etc. recited in instant claim 1.
As indicated in MPEP 2112.01(II), the combined references of Nilsson and Iwaki teach all of the limitations of the claims including the structures of the saccharide derivatives encompassed by the limitations as recited in claim 1. Applicant has not shown that the specific modifications recited in claim 1, and/or the improvements in properties were unknown in the prior art including the ability of the disaccharide derivatives to bind galectins. Thus, the derivatives as taught by the cited references have the same properties as the protein-binding product recited in instant claim 1. Thus, the claims remain rejected.
New Objections/Rejections
Claim Objections
Claims 1, 4, 6, 7, 9, 10, 12, 17, 18 and 20 are objected to because of the following informalities: Claims 1, 4, 6, 7, 9, 10, 12, 17, 18 and 20 recite a mixture of pronouns including “the” and “said” within each claim, such that for consistency, a single pronoun reciting either “the” or “said” should be used.
Appropriate correction is required.
Claims 1, 6 and 7 are objected to because of the following informalities: Claims 1, 6 and 7 recite the term "mmol” and “mL”, where an abbreviation should be spelled out in the first encounter of the claims.
Appropriate correction is required.
Double Patenting Objection
Claim 6 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. Claim 6 recites “wherein the disaccharide ligand is in a range of 0.1-20 mmol per mL polymer” in lines 1-2; while claim 1 recites “wherein a disaccharide ligand is covalently bound to a surface of said one or more porous polymer beads via an aliphatic or aromatic spacer in a range of 0.1-20 mmol per mL polymer” in lines 2-4. Therefore, claim 6 does not differ in scope from claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6, 17 and 20 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 recites (in part): “wherein the disaccharide ligand is in a range of 0.1-20 mmol per mL polymer” in claim 6, lines 1-2. Claim 6 depends from claims 1, wherein instant claim 1 recites that the ‘disaccharide ligand is covalently bound to a surface of said one or more porous polymer beads via an aliphatic or aromatic spacer in a range of 0.1-20 mmol per mL polymer’. Thus, claim 6 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 17 recites (in part): “further comprises one or more porous polymer beads with a covalently bound carbohydrate or carbohydrate derivative compound or ligand that binds an antibody…or human blood plasma toxin” in claim 17, lines 1-4. Claim 17 depends from claims 1, wherein instant claim 1 does not recite a carbohydrate that is not a 3-OH derivative and/or any carbohydrate derivative compounds. Thus, claim 17 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 20 recites (in part): “wherein the ligand is a blood group A or B antigen” in lines 1-2 because claim 20 depends from instant claims 1 and 17, wherein claim 17 recites very specific blood group A and/or blood group B antigens, such that claim 20 recites language that is broader than the specific antigens recited in claim 17. Thus, claim 20 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Conclusion
Claims 1, 4, 6, 7, 9, 10, 12, 17, 18 and 20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M BUNKER whose telephone number is (313) 446-4833. The examiner can normally be reached on Monday-Friday (6am-2:30pm).
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/AMY M BUNKER/Primary Examiner, Art Unit 1684
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