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
Applicant’s claim for the benefit of a prior-filed application (CON of 17/934,950, filed 23 September 2022) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India on 24 September 2021. It is noted, however, that applicant has not filed a certified copy of the IN202121043419 application as required by 37 CFR 1.55.
Thus, the earliest effective filing date of the invention is 23 September 2022.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 14 October 2025 has been entered.
Claim Interpretation
Claim 24 recites a list of limitations in the alternative (due to the use of the transitional phrase “and/or” before step (d)), i.e., only one of the steps (a), (b), (c), and (d) is required to be performed or met.
Claim Objections
Claim 1 is objected to because of the following informalities:
“A process for the preparation of a stable protein solution comprising…”;
“d) loading the treated protein solution onto a matrix for Hydrophobic Interaction Chromatography”;
“e) eluting the treated protein solution from the Hydrophobic Interaction Chromatography matrix”;
“…has an improved stability, is free of sugars…” (add a comma);
“and an undesired impurity of the Fab region and undesired impurities of the Fc region are reduced…”;
“wherein said undesired impurity of the Fab region and said undesired impurities of the Fc region have reduced peak areas on day 7”; and
“wherein the treated protein solution has an improved peak area”.
Claim 5 is objected to because of the following informalities:
“wherein the Hydrophobic Interaction Chromatography (HIC) matrix is a phenyl ligand-based column”.
Claim 13 is objected to because of the following informalities:
“wherein the digested protein solution produced from step (a) comprises antibodies…”.
Claim 24 is objected to because of the following informalities:
“(c) binding is performed at a ratio of at least 95% of mobile phase A to the total volumetric mixture of the mobile phase A and the mobile phase B
Claim 28 is objected to because of the following informalities:
“wherein the increasing of the ratio of the mobile phase B…”.
Claim 29 is objected to because of the following informalities:
“wherein the increasing of the ratio of the mobile phase B…”.
Appropriate correction 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(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.
Claims 1, 3, 5, 10-19, 22-30, 32, 33, and 35 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 limitation “said protein is Omalizumab” lacks antecedent basis and therefore, renders the claim indefinite. No previous limitation introduced a “protein”; multiple limitations have introduced different types of “protein solution”, e.g., “[a] stable protein solution”, “a protein solution”, “a digested protein solution”, and “a treated protein solution”, but none have claimed a “protein” per se. Claims 3, 5, 10-19, 22-30, 32, 33, and 35 are also rejected due to their dependence on Claim 1.
Regarding Claim 1, the limitation “the Hydrophobic Interaction Chromatography Matrix” lacks antecedent basis and therefore, renders the claim indefinite.
Regarding Claim 1, it is unclear which step the claimed “reduced peak area[s] on day 7” is referencing, e.g., the treatment step (a), the incubation step (b), or the treatment step (c)? Presumably, Applicant intends on referencing step (c); however, as claimed, this is not clear and fails to particularly point out and distinctly claim the subject matter and therefore, renders the claim indefinite.
Regarding Claim 24, the claim is indefinite for reciting improper Markush language. Specifically, the limitations requiring “the mobile phase A comprises…” and “the mobile phase B comprises…” lists materials from open lists of alternatives. It is unclear as to what other alternatives are intended to be encompassed by the claim.
A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022) (each independent claim recites "a selection from the group comprising a person, an animal, an animated character, a creature, an alien, a toy, a structure, a vegetable, and a fruit." … (emphasis added). "Given the breadth of variation among the specified alternatives and the use of the open-ended word ’comprising’ to define the scope of the list, we affirm the Board's conclusion that the pending claims recite improper Markush language and are indefinite under § 112(b)."). If a claim is intended to encompass combinations or mixtures of the alternatives set forth in the Markush grouping, the claim may include qualifying language preceding the recited alternatives (such as "at least one member" selected from the group), or within the list of alternatives (such as "or mixtures thereof"). Id. at 1281. See also MPEP § 2111.03. Claims 25-30, 32, 33, and 35 are also rejected due to their dependence on Claim 24.
Claims 30 and 32 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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.
Regarding Claim 30, the claim requires that mobile phase A comprise Tris(hydroxymethyl)amino methane and ammonium sulphate. However, Claim 24 upon which Claim 30 depends, has limited mobile phase A to comprise either ammonium chloride, sodium chloride, Tris(hydroxymethyl)amino methane, or ammonium sulphate, i.e., the claim construction in Claim 24 indicates that mobile phase A can have only one of the listed alternatives. For example, if mobile phase A contains ammonium sulphate, then it cannot have ammonium chloride, sodium chloride, or Tris(hydroxymethyl)amino methane. Claim 30 expands on this selection by requiring more than one alternative from the list delimited in Claim 24 and therefore, fails to include all the limitations of Claim 24.
Similarly, regarding Claim 32, the claim is rejected for failing to include all the limitations of Claim 24.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 3, 5, 10-19, 22-30, 32, 33, and 35 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The claimed invention is directed to a process for preparing a stable protein solution containing the antibody Omalizumab. Briefly, the process entails pretreating and incubating an antibody solution with a protease enzyme, subjecting to a protease inhibitor, then isolating and purifying Omalizumab via hydrophobic interaction chromatography. While the prior art of record, NGO et al. (US 5,328,834) in view of HERGISTAD et al. (US 2016/0115193 A1) discloses the broad steps as claimed, i.e., treatment of an antibody protein solution with a protease enzyme followed by inactivation of the enzyme with an inhibitor and subsequently purifying/isolating the desired antibody via HIC, the prior art fails to explicitly disclose Omalizumab as the target protein of interest or that undesired fragments or proteins are reduced on day 7 of presumably incubation.
Response to Amendments/Arguments
Applicant’s amendments filed 14 October 2025 have been fully considered.
Regarding the Specification Objections, Applicant’s amendments to the Specification are sufficient; these objections have been withdrawn.
Regarding the Claim Objections of Claim 1, Applicant’s amendments are sufficient; this objection has been withdrawn. However, please note the number of new Claim Objections for Claims 1, 5, 13, 24, 28, and 29.
Regarding the rejections of Claims 1, 3, 5, 10-19, and 22-35 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, Applicant’s amendments to Claim 1 are sufficient; these rejections have been withdrawn. However, please note the added rejections of Claims 1, 3, 5, 10-19, 22-30, 32, 33, and 35 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite.
Regarding the rejections of Claim(s) 1, 3, 5, 10-19, and 22-35 under 35 U.S.C. 103 as being unpatentable over NGO et al. (US 5,328,834) in view of HERGISTAD et al. (US 2016/0115193 A1), Applicant’s amendments are sufficient; these rejections have been withdrawn.
Applicant’s arguments filed 14 October 2025 have been fully considered but are not persuasive as they are directed to limitations not considered patentable and further are directed toward grounds of rejection that have been withdrawn. Therefore, the arguments are not commensurate in scope with the presently pending claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN B HUANG whose telephone number is (571)270-0327. The examiner can normally be reached 9 am-5 pm EST.
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/Ryan B Huang/Primary Examiner, Art Unit 1777