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 .
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 35-38, 42 and 50-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40-44, 46 and 56-59 of copending Application No. 18/383,444. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a combination of limitations which are fully encompassed in or otherwise overlap metes and bounds of limitations of claims of application ‘444.
The instant claims are compared with the claims of application ’444 in the following side-by-side comparison:
35. A separation media comprising:
a support substrate; and
a plurality of separation ligands for formula SL1 or SL2
Rp¹-Z -Rp³-Sp-Rp⁴-Z (SL1) (SL2)
wherein:
Z is a separation group comprising an affinity group, the affinity group comprising a carbohydrate, a small molecule, or both; and Rp¹, Rp³, and Rp⁴ each independently comprise the reaction product of any one of Rp⁴, RpB, Rpᶜ, Rpᵇ, RpE, RpF, RpG, Rpᴴ, Rp¹, RpJ, Rpᵏ, or an isomer thereof, wherein Rp⁴, Rpᵇ, Rpᶜ, RpD, RpE, RpF, Rpᶜ, Rpᴴ, Rp¹, Rp¹, and Rpᵏ are represented by: (chemical formula diagrams for RPA – RPK)
wherein: U⁰, U¹, U², U³, U⁴, U⁵, U⁶, and U⁷ are each independently NH, O, or S; Sp is a spacer comprising a divalent organic group, and
wherein the separation media is configured for isolating a target molecule comprising a carbohydrate binding domain. (all encompassed in ‘444, claim 40)
36. The separation media of claim 35, wherein the alkanediyl or alkenediyl comprises a backbone chain of length C1 to C3. (‘444, claims 41 and 42, in combination)
37. The separation media of claim 35, wherein Sp comprises -C(O)-. (‘444, claim 43)
38. The separation media of claim 35, wherein Rp³ and Rp⁴ comprises RpE. (‘444, claim 44)
42. The separation media of claim 35, wherein the support substrate comprises a polyolefin membrane, a polyethersulfone membrane, a poly(tetrafluoroethylene) membrane, a nylon membrane, a fiberglass membrane, a hydrogel membrane, a hydrogel monolith, a polyvinyl alcohol membrane, a cellulose membrane, a cellulose ester membrane, a cellulose acetate membrane, a regenerated cellulose membrane, a cellulosic nanofiber membrane, a cellulosic monolith, a filter paper, or any combination thereof. (‘444, claim 46)
50. A separation device comprising a housing and the separation media of claim 35 disposed within the housing. (‘444, claim 56)
51. A method of isolating a target molecule from an isolation solution: the isolation solution comprising:
an isolation solvent;
the target molecule comprising a carbohydrate recognizing domain; the method comprising:
contacting the isolation solution with the separation media of claim 35. (‘444, claim 57)
52. The method of claim 51, wherein the method further comprises washing the separation media with a washing solution. (‘444, claim 58)
53. The method of claim 51, wherein the method further comprises eluting the target molecule from the separation media. (‘444, claim 59)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 35-40 and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-35 and 37 of copending Application No. 18/383,468. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a combination of limitations which are fully encompassed in or otherwise overlap metes and bounds of limitations of claims of application ‘468.
The instant claims are compared with the claims of application ’468 in the following side-by-side comparison:
35. A separation media comprising:
a support substrate; and
a plurality of separation ligands for formula SL1 or SL2
Rp¹-Z -Rp³-Sp-Rp⁴-Z (SL1) (SL2)
wherein:
Z is a separation group comprising an affinity group, the affinity group comprising a carbohydrate, a small molecule, or both; and Rp¹, Rp³, and Rp⁴ each independently comprise the reaction product of any one of Rp⁴, RpB, Rpᶜ, Rpᵇ, RpE, RpF, RpG, Rpᴴ, Rp¹, RpJ, Rpᵏ, or an isomer thereof, wherein Rp⁴, Rpᵇ, Rpᶜ, RpD, RpE, RpF, Rpᶜ, Rpᴴ, Rp¹, Rp¹, and Rpᵏ are represented by: (chemical formula diagrams for RPA – RPK)
wherein: U⁰, U¹, U², U³, U⁴, U⁵, U⁶, and U⁷ are each independently NH, O, or S; Sp is a spacer comprising a divalent organic group, and
wherein the separation media is configured for isolating a target molecule comprising a carbohydrate binding domain. (all encompassed in ‘468, claim 29)
36. The separation media of claim 35, wherein the alkanediyl or alkenediyl comprises a backbone chain of length C1 to C3. (‘468, claim 30)
37. The separation media of claim 35, wherein Sp comprises -C(O)-. (‘468, claim 31)
38. The separation media of claim 35, wherein Rp³ and Rp⁴ comprises RpE. (‘468, claim 32)
39. (New) The separation media of claim 38, wherein each U⁵ is O, each U⁵ is NH, or one U⁵ is NH and U⁵ is O. (‘468, claim 33)
40. (New) The separation media of claim 35, wherein SL2 comprises (chemical formula diagrams for SL2). (‘468, claims 34 and 35 in combination)
42. The separation media of claim 35, wherein the support substrate comprises a polyolefin membrane, a polyethersulfone membrane, a poly(tetrafluoroethylene) membrane, a nylon membrane, a fiberglass membrane, a hydrogel membrane, a hydrogel monolith, a polyvinyl alcohol membrane, a cellulose membrane, a cellulose ester membrane, a cellulose acetate membrane, a regenerated cellulose membrane, a cellulosic nanofiber membrane, a cellulosic monolith, a filter paper, or any combination thereof (‘468, claim 46).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 35-40, 42 and 50-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-39, 41 and 49-52 of copending Application No. 18/383,464 in view of Jones et al PGPUBS Document US 2020/0330899 (Jones).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a combination of limitations which are fully encompassed in or otherwise overlap metes and bounds of limitations of claims of application ‘464, with the exception of the instant claims additionally reciting wherein the separation media is configured for isolating a target molecule comprising a carbohydrate binding domain.
Jones teaches separation media comprising a support substrate and an affinity group or ligand. Jones teaches that such affinity group can be lectin (concanavalin A) which is a carbohydrate binding domain [0052].
It would have been obvious to one of ordinary skill in the separation media art, to have replaced or augmented the affinity group of the claims of the copending application, with a carbohydrate binding domain, specifically concanavalin A, as taught by Jones, because Jones demonstrates the simple substitution of one known affinity group for another known affinity group, obviously resulting in the ability to bind carbohydrates to the media.
The instant claims are otherwise compared with the claims of application ’464 in the following side-by-side comparison:
35. A separation media comprising:
a support substrate; and
a plurality of separation ligands for formula SL1 or SL2
Rp¹-Z -Rp³-Sp-Rp⁴-Z (SL1) (SL2)
wherein:
Z is a separation group comprising an affinity group, the affinity group comprising a carbohydrate, a small molecule, or both; and Rp¹, Rp³, and Rp⁴ each independently comprise the reaction product of any one of Rp⁴, RpB, Rpᶜ, Rpᵇ, RpE, RpF, RpG, Rpᴴ, Rp¹, RpJ, Rpᵏ, or an isomer thereof, wherein Rp⁴, Rpᵇ, Rpᶜ, RpD, RpE, RpF, Rpᶜ, Rpᴴ, Rp¹, Rp¹, and Rpᵏ are represented by: (chemical formula diagrams for RPA – RPK)
wherein: U⁰, U¹, U², U³, U⁴, U⁵, U⁶, and U⁷ are each independently NH, O, or S; Sp is a spacer comprising a divalent organic group, and
wherein the separation media is configured for isolating a target molecule comprising a carbohydrate binding domain. (all encompassed in ‘464, claim 34)
36. The separation media of claim 35, wherein the alkanediyl or alkenediyl comprises a backbone chain of length C1 to C3. (‘464, claim 35)
37. The separation media of claim 35, wherein Sp comprises -C(O)-. (‘464, claim 36)
38. The separation media of claim 35, wherein Rp³ and Rp⁴ comprises RpE. (‘464, claim 37)
39. (New) The separation media of claim 38, wherein each U⁵ is O, each U⁵ is NH, or one U⁵ is NH and U⁵ is O. (‘464, claim 38)
40. (New) The separation media of claim 35, wherein SL2 comprises (chemical formula diagrams for SL2). (‘464, claim 39)
42. The separation media of claim 35, wherein the support substrate comprises a polyolefin membrane, a polyethersulfone membrane, a poly(tetrafluoroethylene) membrane, a nylon membrane, a fiberglass membrane, a hydrogel membrane, a hydrogel monolith, a polyvinyl alcohol membrane, a cellulose membrane, a cellulose ester membrane, a cellulose acetate membrane, a regenerated cellulose membrane, a cellulosic nanofiber membrane, a cellulosic monolith, a filter paper, or any combination thereof (‘464, claim 41).
50. A separation device comprising a housing and the separation media of claim 35 disposed within the housing. (‘464, claim 49)
51. A method of isolating a target molecule from an isolation solution: the isolation solution comprising:
an isolation solvent;
the target molecule comprising a carbohydrate recognizing domain; the method comprising:
contacting the isolation solution with the separation media of claim 35. (‘464, claim 50)
52. The method of claim 51, wherein the method further comprises washing the separation media with a washing solution. (‘464, claim 51)
53. The method of claim 51, wherein the method further comprises eluting the target molecule from the separation media. (‘464, claim 52)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 35-40, 42 and 51-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 18-20 of copending Application No. 18/925,848 in view of Jones et al PGPUBS Document US 2020/0330899 (Jones).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a combination of limitations which are fully encompassed in or otherwise overlap metes and bounds of limitations of claims of application ‘848, with the exception of the instant claims additionally reciting wherein the separation media is configured for isolating a target molecule comprising a carbohydrate binding domain instead of reciting the separation group comprising an affinity group capable of binding a peptide purification tag on a target protein.
Jones teaches separation media comprising a support substrate and an affinity group or ligand. Jones teaches that such affinity group can be lectin (concanavalin A) which is a carbohydrate binding domain [0052].
It would have been obvious to one of ordinary skill in the separation media art, to have replaced or augmented the affinity group of the claims of the copending application, with a carbohydrate binding domain, specifically concanavalin A, as taught by Jones, because Jones demonstrates the simple substitution of one known affinity group for another known affinity group, obviously resulting in the ability to bind carbohydrates to the media.
The instant claims are otherwise compared with the claims of application ’464 in the following side-by-side comparison:
35. A separation media comprising:
a support substrate; and
a plurality of separation ligands for formula SL1 or SL2
Rp¹-Z -Rp³-Sp-Rp⁴-Z (SL1) (SL2)
wherein:
Z is a separation group comprising an affinity group, the affinity group comprising a carbohydrate, a small molecule, or both; and Rp¹, Rp³, and Rp⁴ each independently comprise the reaction product of any one of Rp⁴, RpB, Rpᶜ, Rpᵇ, RpE, RpF, RpG, Rpᴴ, Rp¹, RpJ, Rpᵏ, or an isomer thereof, wherein Rp⁴, Rpᵇ, Rpᶜ, RpD, RpE, RpF, Rpᶜ, Rpᴴ, Rp¹, Rp¹, and Rpᵏ are represented by: (chemical formula diagrams for RPA – RPK)
wherein: U⁰, U¹, U², U³, U⁴, U⁵, U⁶, and U⁷ are each independently NH, O, or S; Sp is a spacer comprising a divalent organic group, and
wherein the separation media is configured for isolating a target molecule comprising a carbohydrate binding domain. (all encompassed in ‘848, claim 1)
36. The separation media of claim 35, wherein the alkanediyl or alkenediyl comprises a backbone chain of length C1 to C3. (‘848, claim 2)
37. The separation media of claim 35, wherein Sp comprises -C(O)-. (‘848, claim 3)
38. The separation media of claim 35, wherein Rp³ and Rp⁴ comprises RpE. (‘848, claim 4)
39. (New) The separation media of claim 38, wherein each U⁵ is O, each U⁵ is NH, or one U⁵ is NH and U⁵ is O. (‘848, claim 4)
40. (New) The separation media of claim 35, wherein SL2 comprises (chemical formula diagrams for SL2). (‘848, claims 5 and 6 in combination)
42. The separation media of claim 35, wherein the support substrate comprises a polyolefin membrane, a polyethersulfone membrane, a poly(tetrafluoroethylene) membrane, a nylon membrane, a fiberglass membrane, a hydrogel membrane, a hydrogel monolith, a polyvinyl alcohol membrane, a cellulose membrane, a cellulose ester membrane, a cellulose acetate membrane, a regenerated cellulose membrane, a cellulosic nanofiber membrane, a cellulosic monolith, a filter paper, or any combination thereof (‘848, claim 7).
51. A method of isolating a target molecule from an isolation solution: the isolation solution comprising:
an isolation solvent;
the target molecule comprising a carbohydrate recognizing domain; the method comprising:
contacting the isolation solution with the separation media of claim 35. (‘848, claim 18)
52. The method of claim 51, wherein the method further comprises washing the separation media with a washing solution. (‘848, claim 19)
53. The method of claim 51, wherein the method further comprises eluting the target molecule from the separation media. (‘848, claim 20)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claims 35-54 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding Claim 35:
the claim states "a plurality of separation ligands for formula SL1 or SL2...". The term "for" renders the claim indefinite because it is not clear it is a typographical error and should be, for example, "of", or if the claim is intending the plurality of ligands to have a use "for" the formulas SL1 or SL2. It is not clear how a ligand can be "for" a formula, for the purpose of examination the claim will be interpreted as requiring a plurality of separation ligands "of" formula SL1 and/or SL2; and,
the claim states "Rp1, Rp³, and Rp⁴ (groups) each independently comprise the reaction product of any one of..."; this limitation renders the claim indefinite because it is not clear whether two or more elements are being combined to form the "product", it is not clear whether each of the groups of the reaction product can be "of any one of...".
Regarding Claim 36, "the alkanediyl or alkenediyl" lacks antecedent basis for this limitation within the claims.
Regarding Claim 37, the claim further limits "Sp", however, in independent claim 35, "Sp" is only required in the alternative in independent claim 37, if formula SL2 is used. It is therefore not clear is SL2 is being required or Sp is only being limited if SL2 is present.
Regarding Claim 38, the claim further limits Rp3 and Rp4, however "Rp3" and "Rp4" are only required in the alternative in independent claim 35. It is therefore not clear if Rp3 and Rp4 are being required or are only being limited if Rp3 and/or Rp4 is/are present.
Regarding Claim 39, the claim further limits the term U5, however such term is only required in the alternative in independent claim 35. It is therefore not clear if the term U5 is required or is only being limited if the term is present.
Regarding Claim 40, the claim further limits the term SL2, however such term is only required in the alternative in independent claim 35. It is therefore not clear if the term SL2 is required or is only being limited if the term is present.
Regarding Claim 41, “the separation ligand formula SL” lacks antecedent basis, and the claim further limits the term SL1, however such term is only required in the alternative in independent claim 35. It is therefore not clear if the term SL1 is required or is only being limited if the term is present.
Regarding Claim 43, the claim further limits the term “carbohydrate”, however such term is only required in the alternative in independent claim 35. It is therefore not clear if the term “carbohydrate” is required or is only being limited if the term is present.
Claim 43 and claims 44-49 dependent directly or indirectly from claim 43, are also ambiguous, since it is unclear whether the claim term “the carbohydrate” refers back to the claim 35 recitation of the “Z” separation group comprising an affinity group comprising, in the alternative, “a carbohydrate”, or instead, refers back to the claim 35 recitation of “target molecule comprising a carbohydrate binding domain”.
Claim Interpretation
For the purpose of examination, independent claim 35, and thus each of claims 36-54 dependent either directly or indirectly therefrom, will be interpreted on the merits as requiring a plurality of separation ligands "of" formula SL1 and/or SL2.
Additionally, each of claims 36-43 will be interpreted on the merits as actually including or positively reciting the respective terms or units, and respective further limitations for such terms or units, for which antecedent basis is lacking and/or for which the respective terms or units are recited in the alternative in independent claim 35.
Additionally, in each of claims 43-47, the terminology “carbohydrate” and “glycan” will be interpreted on the merits as reciting glycan as being a carbohydrate, ligand affinity group, of the plurality of separation ligands recited in instant independent claim 35, in view of such characterization of carbohydrate ligands in the instant Detailed Description of the Invention, or in the corresponding PGPUBS Document US 20240189797 in paragraphs [0060-0062].
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 35, 37-42 and 50-53 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Zhou et al PGPUBS Document US 2020/0188859 (Zhou). Referenced paragraph numbers of the Descriptions of the applied PGPUBS Documents are identified with “[ ]” symbols.
For independent claim 35, Zhou discloses: A separation media [0016 “adsorptive media”] comprising:
a support substrate [0011, 0016, 0063 re various forms of membranes, monoliths and macroporous supports] ; and
a plurality of separation ligands for or of the formula SL1 or SL2 ([0062],
of the formula Rp¹-Z -Rp³-Sp-Rp⁴-Z (SL1) (SL2)
wherein:
Z is a separation group comprising an affinity group, the affinity group comprising a carbohydrate, a small molecule, or both; and Rp¹, Rp³, and Rp⁴ each independently comprise the reaction product of any one of Rp⁴, RpB, Rpᶜ, Rpᵇ, RpE, RpF, RpG, Rpᴴ, Rp¹, RpJ, Rpᵏ, or an isomer thereof, wherein Rp⁴, Rpᵇ, Rpᶜ, RpD, RpE, RpF, Rpᶜ, Rpᴴ, Rp¹, Rp¹, and Rpᵏ are represented by: (see the instantly claimed chemical formula diagrams for RPA – RPK) (all disclosed in figures 4 and 5, and described in [0089-0090, 0100] and shown in figures 4 and 5)
wherein: U⁰, U¹, U², U³, U⁴, U⁵, U⁶, and U⁷ are each independently NH, O, or S (figure 4 showing a separation ligand having a formula SL2, wherein U5 of Rp3 is O and U5 of Rp4 is NH);
Sp is a spacer comprising a divalent organic group (see the carbonyl groups shown in figures 4 or 5 and described as optionally present in [0085 and 0095]); and
wherein the separation media is optionally configured for isolating a target molecule comprising a carbohydrate binding domain [0101 and 0110 re ligands produced by addition of Protein A solutions to form ligands configured to form Concanavalin A solution to target “glycoproteins” (glycoproteins inherently comprise carbohydrates) .
Zhou further discloses:
for claim 37, the separation media of claim 35, wherein Sp comprises -C(O)- (see fig 4 illustrating a carbonyl group);
for claim 38, the separation media of claim 35, wherein Rp³ and Rp⁴ comprises RpE (figure 4 showing a separation ligand having a formula SL2, wherein U5 of Rp3 is O and U5 of Rp4 is NH);
for claim 39, the separation media of claim 38, wherein each U⁵ is O, each U⁵ is NH, or one U⁵ is NH and U⁵ is O (again, see figure 4 showing a separation ligand having a formula SL2, wherein U5 of Rp3 is O and U5 of Rp4 is NH);
for claim 40, the separation media of claim 35, wherein SL2 comprises (see the instantly claimed chemical formula diagrams of claim 40), wherein n is 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 (figs 1-4, and see [0118 and 0122 regarding Protein A being replaced with Con A]);
for claim 41, the separation media of claim 35, wherein the separation ligand formula SL or SL1 is of formula X, XI, XII, or XIII: (see the instantly claimed, corresponding chemical formula diagrams of claim 41),wherein n is 0, 1, 2, 3, or 4;
wherein X in the formula is NH₂ or PGN where PGN is an amine protecting group;
wherein Y is Y is OH or a PGC(O)OH where PGC(O)OH is a carboxylic acid protecting group; wherein R¹ is an amino acid side chain (see the instantly claimed, corresponding chemical formula diagram of claim 41); or
wherein j is 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10; wherein each RX is independently an amino acid side chain or wherein at least one RX is (see the instantly claimed, corresponding chemical formula diagram of claim 41), (see figures 1 and 4 and [0118 and 0122 regarding Protein A being replaced with Con A]);
for claim 42, the separation media of claim 35, wherein the support substrate comprises a polyolefin membrane, a polyethersulfone membrane, a poly(tetrafluoroethylene) membrane, a nylon membrane, a fiberglass membrane, a hydrogel membrane, a hydrogel monolith, a polyvinyl alcohol membrane, a cellulose membrane, a cellulose ester membrane, a cellulose acetate membrane, a regenerated cellulose membrane, a cellulosic nanofiber membrane, a cellulosic monolith, a filter paper, or any combination thereof [0017 and 0078 regarding any of the above types of membranes];
for claim 50, the separation device comprising a housing and the separation media of claim 35 disposed within the housing (see [0008 re the membranes being used in prepacked chromatography columns, i.e. housing in the form of a packed column]);
for claim 51, a method of isolating a target molecule from an isolation solution ([0010 and 0061 re binding target molecules to ligand which comprise coupling groups of a membrane] and [0058-0059 re biological material being purified passing through a column containing the membrane as a total volume of a solution, i.e. “isolation solution”]): the isolation solution comprising:
an isolation solvent (the solution passing through the column necessarily comprising at least one solvent, i.e. “isolation solvent” of [0058-0059], or alternatively see [0099 re the Concanavilin A solution to target glycoproteins]);
the target molecule comprising a carbohydrate recognizing domain ([0058 and 0061] and [0099 and 0122 re binding of a carbohydrate binding domain of a lectin or Concanavalin A]); the method comprising:
contacting the isolation solution with the separation media of claim 35 (again see [0010, 0058-0059 and 0061] and see the above detailed claim-mapping discussion of Zhou with respect to individual limitations of claim 35);
for claim 52, wherein the method further comprises washing the separation media with a washing solution [0059 regarding a rinsing, i.e. “washing” step]; and,
for claim 53, wherein the method further comprises eluting the target molecule from the separation media [0059 re elution].
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 factual inquiries 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.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al PGPUBS Document US 2020/0188859 (Zhou), as applied to claims 35, 37-42 and 50-53, in view of the Escapenet Machine translation of Momiyama patent publication WO 2015199196A1 (Momiyama). Referenced paragraph numbers of the Description of the applied PGPUBS Document are identified with “[ ]” symbols.
Claim 36 differs from Zhou by requiring wherein an alkanediyl or alkenediyl separation ligand group of the separation media comprises a backbone chain of length C1 to C3.
Momiyama teaches an affinity separation ligand group of a separation media containing an alkanediyl or alkenediyl separation ligand group which comprises a backbone chain of length C1 to C3 (page 3, 2nd full paragraph regarding affinity solid chromatography support having a ligand bound to the solid support, and page 21 regarding a ring-opened epoxy group which prevents non-specific adsorption of impurities and decreases in ligand activity during storage, with page 22 describing such groups as preferably being an alkanediyl group and page 23, 1st full paragraph describing such ligands imparting dynamic binding capacity and anti-fouling properties).
It would have been obvious to one of ordinary skill in the art of utilizing separation media having ligands to isolate target molecules, to provide an additional ligand group of the separation media comprising an alkanediyl or alkenediyl separation ligand group, as taught by Momiyama, in order to prevent non-specific adsorption of impurities and decreases in ligand activity during storage, and imparting dynamic binding capacity and anti-fouling properties.
Claims 43-49 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al PGPUBS Document US 2020/0188859 (Zhou), as applied to claims 35, 37-42 and 50-53, and in view of Sasisekharan et al PGPUBS Document US 2009/0269342 (Sasisekharan) .
Referenced paragraph numbers of the Descriptions of the applied PGPUBS Documents are identified with “[ ]” symbols.
Claim 43, and claims 44-47 dependent from claim 43, differ from Zhou by requiring a carbohydrate affinity group of at least one separation ligand to comprise a carbohydrate which comprises a glycan.
Sasisekharan teaches a carbohydrate affinity group of at least one separation ligand to comprise a carbohydrate which comprises a glycan ([0014 regarding alpha2-3- and/or alpha 2-6 linked or branched oligosaccharides forming the glycans and suggesting obviousness of selection of such type glycans for affinity groups since they are configured to bind with HA polypeptides so as to mediate infection of different hosts including humans], [0067-0068 concerning binding glycans, in some embodiments being carbohydrate binding agents] and [0094 and 0124 regarding glycans having an umbrella-topology adapted for binding to amino acids and having high affinity with HA (hemagglutinin)]) .
It would have been obvious to one of ordinary skill in the art of providing separation media utilizing affinity groups of separation ligands, to have selected at least one separation ligand to comprise a carbohydrate which comprises a glycan, as taught by Sasisekharan, in order to facilitate binding and separation of amino acids and having a particularly high affinity for binding hemagglutinin, and so as to mediate infection of different hosts including humans.
Sasisekharan further teaches or suggests the following :
for claim 44, wherein the glycan has a linear structure (see [0014 regarding glycans comprising “certain long oligosaccharides], [0014 suggesting obviousness selection of such type glycans for affinity groups since they are configured to bind with HA polypeptides so as to mediate infection of different hosts including humans]);
for claim 45, wherein the glycan has a branched structure with two terminal ends (see again [0014 regarding alpha2-3- and/or alpha 2-6 linked or branched oligosaccharides forming the glycans], [0014 again suggesting obviousness of selection of such type glycans for affinity groups since they are configured to bind with HA polypeptides so as to mediate infection of different hosts including humans]);
for claim 46, wherein the glycan comprises a terminal sialic acid and an adjacent saccharide, and wherein the terminal sialic acid and the adjacent saccharide are covalently linked through a linkage (suggested by [0022 re sialyated oligosaccharides in respective HA-glycan co-crystal structures], [0014 suggesting obviousness of selection of such type glycans for affinity groups since they are configured to selectively bind with HI and HA avian groups]); and,
for claim 47, wherein the linkage is an α-2,6 linkage or α-2,3 linkage (see again [0014 regarding alpha2-3- and/or alpha 2-6 linked or branched oligosaccharides forming the glycans], [0014 again suggesting obvious selection of such type glycans for affinity groups since they are configured to bind with HA polypeptides so as to mediate infection of different hosts including humans]).
Claims 48 and 54, and claim 49 dependent from claim 48, differ from Zhou, by requiring the separation media of claim 35, being configured for isolating a target media comprising a carbohydrate binding domain, which comprises hemagglutinin.
Sasisekharan teaches a carbohydrate affinity group of at least one separation ligand to be configured for isolating hemagglutinin [0007 regarding glycan binding characteristics having high affinity and selectivity for binding to hemagglutinin receptors] and [0014 to such glycans comprising short or branched oligosaccharides, hence “carbohydrates”]; [0014 suggesting obvious selection of such type glycans for affinity groups since they are configured to bind with HA polypeptides so as to mediate infection of different hosts including humans and selectively bind with HI and HA avian groups]) .
Sasisekharan further teaches the following: for claim 49, wherein the target molecule comprises a recombinant hemagglutinin [0027 regarding binding of recombinant H1 and H3 type of HA groups, and obviousness of selecting affinity groups of ligands for binding to such material so as to mediate infection of tracheal and other respiratory tissue].
It would have been additionally obvious to the skilled artisan to have utilized at least one affinity separation ligand to comprise a carbohydrate which is configured for isolating recombinant hemagglutinin so as to mediate infection of tracheal and other respiratory tissue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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JWD
06/03/2026
/JOSEPH W DRODGE/Primary Examiner, Art Unit 1773
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