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 .
Priority
The present application was filed December 30, 2021 and claims foreign priority based on European Application No. 19184130, filed on July 03, 2019. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C 119 (a) – (d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on August 20, 2024, May 02, 2024, October 10, 2023, and January 13comply with the provision of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Elections/Restrictions
Applicant’s election of group I in the reply filed on February 28, 2025 is acknowledged.
Applicant's election with traverse of Group I in the reply filed on February 28, 2025 is acknowledged. The traversal is on the ground “The Restriction Requirement is respectfully traversed because the separation material of the elected claims in Group I is a feature of the non-elected claims of Group II. Applicants respectfully assert that the separation material of the elected claims in Group I does feature a contribution over the Skudas et al. reference (Journal of Chromatography A, 1144 (2007) 72-84), hereinafter "Skudas". For example, the separation material of claim 1 features polymer chains comprising amino acid end groups -N(Y)-R3 with R3 being -CHCOOMR4, which is absent in Skudas. Therefore, the claims could be examined together without imposing a serious search burden.
Applicant’s arguments have been fully considered and are found persuasive because groups I-II do have unity of invention. After reviewing Skudas, the examiner acknowledges that the shared technical feature “the separation material of claim 1 features polymer chains comprising amino acid end groups -N(Y)-R3 with R3 being -CHCOOMR4” is absent in Skudas. Therefore, the shared technical feature is a special technical feature, and unity of invention is present between groups I-II.
Claims 1-7 are allowable. Claims 8-12, previously withdrawn from consideration as a result of a restriction requirement, requires all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions of Group I and Group II, as set forth in the Office action mailed on 02, 20, 2025, is hereby withdrawn and claims 8-12 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Drawings
The disclosure is objected to because of the following informalities:
Figures 9-12, and 27-29 are missing X and Y-axis labels.
Figures 9-12, in addition to missing the overall labels, the values are too small to read.
Figure 14, 16, 26, 31, and 33 are missing Y-axis labels. Appropriate action is required.
Specification
The disclosure is objected to because of the following informalities:
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Appropriate action is required.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 includes the abbreviation, “µeq/g” which should be defined upon first recitation in the claims.
Claims 9-12 are objected to for lacking an article. The first word of claims 9-12 - “process”, should be “the process”.
Appropriate action is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim includes step a. which states, “Y being independently from each other H or CH3, preferably H”. The term “preferably” is an example of exemplary claim language, which should not be present in the claims. The use of preferably can lead to confusion regarding the choice of the “Y” group. See MPEP § 2173.05(d) Exemplary Claim Language, “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made”.
Claims 2-7, and 12 depend on independent claim 1, and are therefore also indefinite for the same reasons as discussed above.
Claim 2 recites that “each monomer unit comprises an end group -N(Y)-R3” without defining the Y and R3 groups. It is unclear if the end groups in claim 2 are meant to have the same structure, and refer to the same end groups in claim 1.
Claim 2 states that, “each monomer unit comprises an end group -N(Y)-R3”. An end-group typically refers to a group that is present at the terminal portion of a sequence. It is not clear how each monomer within a linear polymer chain would contain an end group.
Claim 3 refers to an “ionic density”, which lacks antecedent basis in the proceeding portion of the claim, and in independent claim 1, which does not recite the term “ionic density”. It is unclear if “ionic density” refers to the separation material, or a component of the separation material. See MPEP § 2173.05 Lack of Antecendent Basis, which states that “The lack of clarity could arise where a claim refers to "said lever" or "the lever," where the claim contains no earlier recitation or limitation of a lever and where it would be unclear as to what element the limitation was making reference.”.
Claim 4 includes the phrase, “R4 is isopropyl and/or isobutyl”. It is not clear how a single R4 group can be both isopropyl and isobutyl. In claim 1 part a, Y is described as “independently selected”, unlike R3 in part b which is not described as “independently selected” and so every moeity must have the same selection for R3. Therefore, the phrase “R4 is isopropyl and/or isobutyl” is indefinite.
Claim 6, as written, it appears grammatically that “divinylethyleneurea (1,3-divinylimidazolin-2-one) as crosslinking agent” could be part of the group of hydrophilically substituted alkyl vinyl ethers. This creates ambiguity regarding whether the divinylethyleneurea is part of the group of ethers, or is meant to be a separate, crosslinking component.
Claim Rejections – 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 1-4, and 8-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending U.S. Application No. 17,623,914. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1 of the instant application, claim 1 of the ‘914 Application recites, “A method for the chromatographic purification and/or separation of protein glycoforms by contacting the sample comprising the protein glycoforms with a separation material comprising of a base matrix to the surfaces of which polymer chains are covalently bonded, characterised in that
the polymer chains comprise end groups —N(Y)—R3 with
Y being independently from each other H or CH3, and
R3 being —CHCOOMR4
with R4 being C1 to C4 alkyl or C1 to C4 perfluoroalkyl
and M being H, Na, K, or NH4.”.
Although claim 1 of the ‘914 application is a method claim, it discloses the exact structure of instant claim 1. Therefore, claim 1 is obvious over claim 1 of the ‘914 application.
Regarding claim 2, claim 8 of the ‘914 application recites, “Method according to claim 1, characterized in that the polymer chains are build by monomer units and the monomer units of the polymer chains are linked in a linear manner and each monomer unit comprises an end group —N(Y)—R3.”. Although claim 8 of the ‘914 application is a method claim, it discloses the exact structural limitations of instant claim 2. Therefore claim 2 is obvious over claim 2 of the ‘914 application.
Regarding claim 3, claim 12 of the ‘914 application recites, “Method according claim 1, characterized in that the sample is applied to the separation material at an ionic density between 10-1200 μeq/g.”. The claimed range of “400-900ueq/g” lies entirely within the range disclosed in the ‘914 application claim 12 (10-1200 μeq/g). A person with ordinary skill in the art would find it prima facie obvious to use the range disclosed in the ‘914 application to arrive at the range in claim 3 of the instant application. See MPEP § 2144.05 - Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions - which states that, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Regarding claim 4, claim 9 of the ‘914 application recites, “Method according to claim 1, characterized in that Y is H and R4 is isopropyl and/or isobutyl.”. Although claim 9 of the ‘914 application is a method claim, it discloses the exact structural limitations of instant claim 4. Therefore, claim 4 is obvious over claim 9 of the ‘914 application.
Regarding claim 8, as discussed in the rejection of claim 1 above, claim 8 of the ‘914 application discloses a method for the chromatographic purification and/or separation of protein glycoforms, and further discloses the same structure as instant claim 1.
Claim 1 of the ‘914 application discloses a method for purification and/or separation of protein glycoforms, it is therefore appropriate to consider the types of glycoforms discussed in the ‘914 specification. The ‘914 specification states, “The present invention relates to a method for the separation and purification of glycoforms with an ion exchange separation material with amino-acid based endgroups. Glycans are an essential part from glycoprotein molecules, assuring its structure and function. One of the most common glycoproteins are immunoglobulins containing two N-linked oligosaccharides at the conserved Asparagine 297 in the CH2 domain of the Fc part. The structure of the glycan is composed of two N-acetylglucosamine (GlcNAc), three mannose and two GlcNAc residues. Additional monosaccharides such as fucose (Fuc), galactose (Gal), sialic acid including N-acetylneuraminic acid (NANA) or N-glycolylneuraminic acid (NGNA) residues can be present as well” (Para 001-003).
A person with ordinary skill in the art would find it prima facie obvious to use the method of the ‘914 application, which discloses the exact same structure as the instant application, for the instantly claimed method of chromatographic purification and/or separation of antibody drug conjugates. This is because the instant claim uses the same structure for the similar method of chromatographic separation or purification of antibody drug conjugates. As antibodies are highly glycosylated, including antibodies in antibody drug conjugates, a person with ordinary skill in the art would find it prima facie obvious to use the method of the ‘914 application for antibody separation and purification. This would include use for antibody drug conjugates. Therefore, the claim is obvious over the ‘914 claim.
Regarding claim 9, claim 11 of the ‘914 application recites, “Method according to claim 1, characterized in that the protein glycoforms are bound to the separation material at a pH between 2 and 7.”. Instant claim 9 is therefore obvious over claim 11 of the ‘914 application for the same reasons as claim 8 above.
Regarding claim 10, claim 10 of the ‘914 application states, “Method according to claim 1, characterized in that the ionic density of the separation material is between 10-1200 μeq/g.”. Instant claim 10 is therefore obvious over claim 10 of the ‘914 application for the same reasons as claim 8 above.
Regarding claim 11, claim 13 of the ‘914 application states, “Method according to claim 1, characterized in that between 10 mg and 100 mg of the protein glycoforms are bound per ml of the separation material.”. Instant claim 11 is therefore obvious over claim 13 of the ‘914 application for the same reasons as claim 8 above.
Claims 1-4 and 8-11 are unpatentable over claims 1-14 of the ‘914 Application.
This is a provisional nonstatutory double patenting rejection.
Claims 5, 7, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending U.S. Application No. 17,623,914 as applied to claim 1-4, and 8-11 above and in further view of claims 1-22 of U.S. Patent No. 8673988B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 5, claim 1 of the ‘988 Patent states, “a) the support material contains aliphatic hydroxyl groups”. Therefore, the instant claim is obvious over the ‘914 Application as applied above, and in further view of claim 1 of the ‘988 Patent.
Regarding claim 7, the ‘988 Patent discloses that the polymer can be prepared in various ways including, “A preferred one-step graft polymerisation reaction can be initiated by cerium(IV) on the hydroxyl-containing support” (Column 9, lines 43-46).
Regarding claim 12, as mentioned above the ‘988 Patent discloses that the polymer can be prepared in various ways including, “A preferred one-step graft polymerisation reaction can be initiated by cerium(IV) on the hydroxyl-containing support” (Column 9, lines 43-46). It would therefore be obvious to a person with ordinary skill in the art to use a method to make the obvious composition of instant claim 7.
Claims 5, 7, and 12 are unpatentable over claims 1-14 of the ‘914 Application as applied to claims 1-4, and 8-11 above and in further view of the ‘988 Patent.
This is a provisional nonstatutory double patenting rejection.
Claims 6 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending U.S. Application No. 17,623,914 as applied to claim 1-4, and 8-11 above and in further view of claims 1-18 of U.S. Patent No. US9975920B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 6, claim 2 of the ‘920 Patent states, “wherein the polyvinylether matrix is a copolymer obtained by copolymerisation of a hydrophilically substituted alkyl vinyl ether selected from: 1,4-butanediol monovinyl ether, 1,5-pentanediol monovinyl ether, diethylene glycol monovinyl ether or cyclohexanedimethanol monovinyl ether; and divinylethyleneurea (1,3-divinylimidazolin-2-one) as crosslinking agent.”. Therefore, the instant claim is obvious over the ‘914 Application as applied above, and in further view of claim 2 of the ‘920 Patent.
Claim 6 is unpatentable over claims 1-14 of the ‘914 Application as applied to claims 1-4, and 8-11 above and in further view of the ‘920 Patent.
This is a provisional nonstatutory double patenting rejection.
Art of Record
Aldinger (U.S. Publication No. US20160046664A1) is directed towards the use of chromatographic material or matrix for anion exchange purification, wherein the matrix is a hydrophilic polyvinyl ether (Page 1, para 0006). Aldinger discloses, “In a very preferred embodiment the matrix is formed by copolymerisation of a hydrophilically substituted alkyl vinyl ether employed selected from the group of 1,4-butanediol monovinyl ether, 1,5-pentanediol monovinyl ether, diethylene glycol monovinyl ether or cyclohexanedimethanol monovinyl ether and divinylethyleneurea (1,3-divinylimidazolin-2-one) as crosslinking agent. In a preferred embodiment, the ionic groups have been attached to the matrix by subjecting the polyvinylether matrix to cerium catalyzed graft polymerization (Page 1, para 0013-0014). Further, the method of purification wherein, “the anion exchange groups have been attached to the matrix by subjecting the polyvinylether matrix to cerium catalyzed graft polymerization.” (Claim 3).
However, Aldinger does not explicitly disclose that the polymer chains amino acid end groups have the structure of N(Y)-R3, according to steps a. and b. of instant claim 1.
Graalfs (U.S. Publication No. US20110136925A1) is directed to a similar invention comprising, “Separating materials…for ion exchange chromatography based on corresponding hydroxyl-containing base supports to the surfaces of which copolymers are covalently bonded…
a) the base support contains aliphatic hydroxyl groups,
b) the copolymers are covalently bonded to the support,
c) the copolymers contain at least two different monomer units,
d) the monomer units are linked in a linear manner,
e) the copolymer has at least one monomer unit which carries a charge in the form of a sulfonic acid or carboxylic acid or in the form of an amine or ammonium group and in addition contains and alkyl and/or alkylene groups and optionally amide groups, but no aryl groups,
f) the copolymer has at least one uncharged monomer unit of the general formula (1)
PNG
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189
621
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in which
R1 denotes hydrogen,
R2 denotes hydrogen or methyl, and
R3 and Y, independently of one another, denote hydrogen, straight-chain alkyl having up to 4 C atoms, methoxypropyl, ethoxyethyl or methoxyethyl …” (Claim 1).
Graalfs further discloses, “2. Separating materials for ion exchange chromatography according to claim 1, characterised in that
e) the copolymer has at least one monomer unit having a charge of the general formula (1), in which
R1 denotes hydrogen,
Y denotes hydrogen and
R3 denotes R4—SO3M, R4—COO, R4—NR9R10 or R4—NR9R10R11X
where
R4 denotes straight-chain or branched alkylene having 2 to 4 C atoms,
…” (Claim 2).
The structure claimed by Graalf and the structure in instant claim 1 each have an N-functional group with a C-C-OO group. The instant application has the whole R4 group off the first carbon from the nitrogen, which Graalf does not suggest. See the images below, which includes formula Va from the instant application, and two embodiments of the structure claimed by Graalf. While the instant application has monomers derived from amino acids, the monomers of Graalf are directed towards charged acrylamides.
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376
1171
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Greyscale
Noetzel, (EP Publication No. EP0129719A2) is directed towards, “A process for the preparation of polymers consisting essentially of units, which differ from monomers of the formula:
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268
1006
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Greyscale
in which X is hydrogen or methyl, R is an aliphatic hydrocarbon radical having 1 to 12 carbon atoms and Y is OH or NH 2, and from units which are derived from at least one further monomer which is reacted with monomers of the formula (I) is copolymerizable” (Page 1, description, para 1). While the monomer units of Noetzel are similar to formula V of instant claim 7, they comprise straight chain alkyl groups with terminal -OH or -NH2 groups, unlike the instant application.
Harrold & Zavod, “Basic Concepts in Medicinal Chemistry”, American Society of Health-System Pharmacists, ISBN: 978-1-158528-266-1, 2013, Chapter 2, pages 1-36, discloses that “alkyl groups, such as a methyl group or an ethyl group can serve as electron donating groups through induction.” (Electron Donating Functional Groups Section). Further, “Common lipid soluble functional groups…include…alkyl groups (aka aliphatic side chains), unsaturated carbon” (Lipid Soluble Functional Groups Section). The disclosure that alkyl groups are electron donating and lipid soluble, indicates that adding an alkyl functional group to the monomers disclosed in the art references would not be obvious without further guidance.
Allowable Subject Matter
Claims 1-12 are allowable over the prior art.
Reasons for Allowance
The following is the examiner’s statement of reasons for allowance:
Independent claim 1 is representative of the pending claims scope and recites a, “A separation material comprising a hydroxyl-group containing base matrix, to the surfaces of which polymer chains are grafted by covalent bonding, characterized in that the polymer chains comprise amino acid end groups -N(Y)-R3 with a. Y being independently from each other H or CH3, preferably H, andb. R3 being -CHCOOMR4 with R4 being C1 to C4 alkyl or C1 to C4 perfluoroalkyl and M being H, Na, K, or NH4.”.
As discussed in the ‘Art of Record’ section above, the inventions of Aldinger (U.S. Publication No. US20160046664A1),Graalfs (U.S. Publication No. US20110136925A1), and Noetzel, (EP Publication No. EP0129719A2) are directed towards similar subject matter to the instant application. Aldinger discloses the production of a separation material from copolymerization of a hydrophillically substituted alkyl vinyl ether and a crosslinking agent, similar to the instant claims. Aldinger discloses the separation material for using in ion exchange chromatography of plasma samples. Graalfs discloses a similar separation material to the instant claim 1, wherein the main inventive difference lies in the lack of the amino acid end groups “-N(Y)-R3 with…R3 being -CHCOOMR4 with R4 being C1 to C4 alkyl or C1 to C4 perfluoroalkyl and M being H, Na, K, or NH4” present in the instant application. Noetzel discloses monomer units similar to formula V of instant claim 7, but they comprise straight chain alkyl groups with terminal -OH or -NH2 groups. There is no disclosure or motivation in Aldinger,Graalfs, or Noetzel that adding amino acid end groups to the monomer units of the separation material would be an obvious modification. As discussed above, alkyl groups are electron donating and lipid soluble, and there is no indication in the references that adding an alkyl functional group to the monomers disclosed would be obvious without further guidance. Further, no such disclosure or motivation was identified by the examiner in the prior art as a whole. Due to the lack of prior art suggesting this feature, independent claim 1 is allowable. Claims 2-12 all depend on independent claim 1, and are therefore allowable.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE RYAN SMITH whose telephone number is (703)756-4642. The examiner can normally be reached Monday-Friday 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Weidner can be reached on (571) 272-3045. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KYLE RYAN SMITHExaminer
Art Unit 1651
/Adam Weidner/SPE, Art Unit 1651
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