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
1. The Amendment filed March 09, 2026 in response to the Office Action of September 08, 2025 is acknowledged and has been entered. Claims 1, 16, 46, 67, 71, 97, 109, 133, 134, and 137 were amended. Claims 2, 18, 68, 85, 115, 127-129, 130-132, 135, and 136 were canceled. New claim 138 has been added.
2. Claims 1, 7, 16, 29, 46, 56-58, 60, 65, 67, 71, 97-99, 107, 109, 112, 133, 134, and 137-138 are pending and under consideration.
3. All objections and rejections recited in the Office Action of September 08, 2025 are withdrawn in view of Applicant’s amendments and arguments.
Rejections Maintained
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.
4. Claim(s) 65 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2017/021493 A1 (Putics et al. Feb. 9, 2017), “Putics”, for the reasons of record.
Putics teaches at the paragraph bridging pp. 5-6: a method for improving the biosimilarity of a therapeutic antibody produced by Chinese hamster ovary cells to its reference antibody, said method comprising the steps of:
a) culturing Chinese hamster ovary cells transformed with one or more recombinant nucleic acid molecules encoding the light and the heavy chain of the therapeutic antibody in a cell culture medium at a pH of 7.15 for a first period of time; b) culturing said Chinese hamster ovary cells in said cell culture medium at a pH of 7.00 for a second period of time; and c) feeding a composition comprising the following components: (i) uridine; (ii) manganese (II) chloride; and (iii) galactose to the culture of (b).
Putics teaches the temperature during the culturing process is set to 36°C to 38°C and more preferably the temperature is set to 37°C. See p. 23-lines 29-30.
Putics teaches the therapeutic antibody can be an antibody that recognizes a4b7, particularly the antibody vedolizumab. See p. 13-line 23 and p. 14-line 9.
Vedolizumab comprises the claimed antibody sequences. See page 40-1st paragraph of the instant specification.
Putics teaches purifying the antibodies with chromatography, including cation exchange chromatography and affinity chromatography. See p. 25-lines 8-18.
Putics teaches that the methods are for producing therapeutic humanized and human antibodies. See p. 15-line 25 to p. 16-line 5 and p. 25-lines 25-30.
Putics teaches that the method is intended to increase the galactosylation of antibodies, in particular G1F and G2F glycoforms. See p. 3-lines 10-20, p. 8-line 23 to p. 9-line 10 and p. 35-line 10 to p.37-line 24.
Putics teaches at p. 10-lines 4-10.
The galactose content is also increased, if the percentage of the G0F isoform in the recombinant protein produced according to the method of the present invention is decreased by at least 1 %, 2% or 3%, preferably by at least 4%, 5% or 6%, more preferably by at least 7%, 8% or 9% and most preferably by at least 10% compared to the percentage of the G0F isoform in the same recombinant protein produced by a cell culture which is maintained at constant pH and to which the composition as
defined above has not been fed.
See also p. 36-line 1 to p. 37-line 5 and Table 5.
In regard to the wherein clauses reciting different amounts or levels of basic, acidic, glycoforms, or isoforms of the humanized anti-a4b7 antibody, it is noted that a wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04. Alternatively given that the method of the prior art comprises the same method steps as claimed in the instant invention, the claimed method is anticipated because the method of the prior art will produce the different amounts or levels of basic, acidic glycoforms, or isoforms of the humanized anti-a4b7 antibody as claimed in the wherein clauses.
Response to Arguments
5. Applicant argues that as an initial matter, claims 2, 18, 68, 85, 115, 127, 129, 130, 132, 135, and 136 are canceled, rendering this rejection moot with respect to those claims.
Independent claims 1 and 97 each are amended to include the subject matter of claims 128 and 131, respectively. Neither claim 128 nor claim 131 is subject to the instant rejection. The pH range cited in amended claims 1 and 97, as well as the specific level of basic isoform in the resulting compositions, are also not disclosed in Putics.
Applicant’s arguments have been considered and have been found partially persuasive. The rejection of claims 1, 2, 18, 56-58, 60, 67, 68, 71, 85, 97, 107, 109, 115, 127, 129, 130, and 132-137 are withdrawn in view of Applicant’s amendments and arguments.
However, regarding claim 65, although the composition of claims 65 is produced by the method of claim 1, product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP 2113 (I). Also given the indefiniteness of claims 65 (see below), the claimed composition is interpreted as not being limited to a particular basic isoform percentage. Thus, the rejection of claim 65 is maintained for the reasons of record.
New Grounds of Objection/Rejection
Specification
6. The use of the term GS-CHO, which is a trade name or a mark used in commerce (see , GS Xceed® Gene Expression System /GS® CHO(Lonza https://www.lonza.com/integrated-biologics/expression-technologies/gs-expression-system, downloaded 05/11/2026), p. 7-FAQ), has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
7. Claims 1, 7, 16, 29, 46, 56-58, 60, 65, 67, 71, 97-99, 107, 109, 112, 133, 134, and 137-138 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.
Claims 1 and 97 contains the trademark/trade name GS-CHO. See GS Xceed® Gene Expression System /GS® CHO (Lonza, https://www.lonza.com/integrated-biologics/expression-technologies/gs-expression-system, downloaded 05/11/2026, p. 1-12), p. 7-FAQ. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a glutamine synthase deficient Chinese hamster ovary cell and, accordingly, the identification/description is indefinite.
Claims depending from claims 1 and 97 are also indefinite because they incorporate by reference the limitations of claims 1 and 97.
Regarding claim 58, claim 58 recites the limitation "the antibody" in line 2 in reference to claim 1. There is insufficient antecedent basis for this limitation in the claim because claim 1 is drawn to “a humanized anti a4b7 antibody”.
Regarding claim 60, claim 60 is rejected because it incorporates by the reference the limitations of claim 58.
Regarding claim 65, claims 65 is drawn to a composition comprising humanized anti-α4b7 antibodies, wherein the composition is produced using or is obtainable by the method of claim 1. Claim 1 is drawn to “wherein the composition comprises about 16% or less basic isoform of the humanized anti- α4ß7 antibody”. Given that 65 does not recite the basic isoform limitation, it is unclear if the compositions of claims 65, 67 and 138 are limited to having the basic isoform levels recited in claim 1. Thus claims 65, 67 and 138 are indefinite.
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.
6. Claim(s) 65 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0341885 A1 (Diluzio et al. Nov. 20 2014), “Diluzio”.
Diluzio teaches a vedolizumab formulation comprising about 5% basic species. See ¶ [0246]. Vedolizumab comprises the humanized anti a4b7 antibody of claim 1. See claim 57.
Although the composition of claim 65 is produced by the method of claim 1, product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP 2113 (I).
7. Claim(s) 65, 67 and 138 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2007/0122404 A1 (O’Keefe, TL May 31, 2007), “O’Keefe” evidenced by Vedolizumab (MeSH-NCBI, https://www.ncbi.nlm.nih.gov/mesh/?term=vedolizumab, downloaded 05/11/2026).
Keefe teaches the carbohydrate profile of MLN02 samples. See ¶¶ 0140-0143. MLN02 is vedolizumab. See Vedolizumab.
Keefe teaches a MLN02 composition with 75% G0F, 20% G1F and 2 % G2F. See Table 2.
Although the composition of claims 65, 67 and 138 is produced by the method of claim 1, product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP 2113 (I).
Also given the indefiniteness of claims 65, 67 and 138, the claimed composition is interpreted as not being limited to a particular basic isoform percentage.
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.
8. Claim 65 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7, 11, 22, 25, 26, 31, 44, 45, 49, 51, 52, 54, 58, 62, 63, 65, 72, 73, 76, 78, 80-82, 85, 86, 90, 91, 93-95, 102, 109, 112, and 113 of co-pending Application No. 17/596,421 (published as US 2022/0267449-A1, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘421 claims are drawn to:
1. (Currently Amended) A method of producing a composition comprising vedolizumab, comprising: providing a composition comprising vedolizumab at a pH of about pH 6.5-8 wherein the composition is derived from a Chinese Hamster Ovary (CHO') cell culture expressing vedolizumab; and incubating the composition comprising vedolizumab for a period of at least 10 hours; wherein the incubation is performed during vedolizumab purification, and wherein the incubation is performed prior to formulation of vedolizumab in a pharmaceutically acceptable buffer, wherein the method reduces the level of basic vedolizumab isoform species, thereby producing a composition comprising vedolizumab having <16% basic vedolizumab isoform species.
49. A composition comprising vedolizumab, wherein the composition is produced by or is obtainable by the method of claim 1.
51. The composition of claim 49, wherein the basic vedolizumab isoform species comprises less than 16%, less than 15%, less than 14%, less than 13%, less than 12%, less than 11%, or less than 10% of the vedolizumab species present in the composition.
Although the composition of claim 65 is produced by the method of claim 1, product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP 2113 (I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
9. All other objections and rejections recited in the Office Action of September 08, 2025 are withdrawn in view of Applicant’s amendments and arguments.
10. No claims allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached on M-F 8:30-5:30 Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch, can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Peter J Reddig/
Primary Examiner, Art Unit 1642
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