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 .
Claim Status
Claims 39 and 40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 1-2, 5, 8, 12, 15, 17, 21, 24, 33, 35, 38, 41, and new claims 42-46 are under consideration in this office action.
Withdrawn Rejections
Any objection or rejection of record pertaining to cancelled claim 7 is rendered moot by applicant’s cancellation of said claim.
The rejections of claims 2, 5, 8, 12, 15, 17, 24, 33, and 35 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of applicant’s amendment filed August 17, 2026.
The rejection of claims 1-2, 5, 8, 12, 15, 17, 21, 24, 33, 35, 38, and 41 under 35 U.S.C. 112(a) as failing to meet the written description is withdrawn in view of applicant’s amendment to limit the anti-IL-5 antibody to one comprising light chain SEQ ID NO: 1 and heavy chain SEQ ID NO: 2.
The rejection of claims 1-2, 5, 7-8, 12, 15, 17, 21, 24, 33, 35, 38, and 41 under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Monck is withdrawn in view of applicant’s amendment to limit the composition to a specific combination of excipients and anti-IL-5 antibody.
New Rejection Necessitated by Amendment
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 1-2, 5, 8, 12, 15, 17, 38, 41, and new claims 42-45 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.
Claim 1 is drawn to a formulation comprising an anti-IL-5 antibody, a histidine buffer, sucrose or sorbitol and polysorbate 80. The scope of the claim is ambiguous. For example, it is unclear if the formulation comprises an anti-IL-5 antibody, a histidine buffer, either sucrose or sugar, and polysorbate 80 or if the polysorbate 80 limitation after “and” in line 5 applies to each anti-IL-5 antibody, histidine buffer, sucrose or sorbitol separately. Because both interpretations are reasonable and materially different, the claim is rejected for being indefinite.
Claims 2, 5, 8, 12, 15, 17, 38, 41, and new claims 42-45 are included in this rejection for being dependent on a rejected base claim and for failing to cure the indefiniteness.
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.
Claims 1-2, 5, 8, 12, 15, 17, 21, 24, 33, 35, 38, 41, and new claims 42-46 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0251539, published September 6, 2018 (“Monck”; PTO-892 from 3/2/2026).
The claims are directed to an anti-IL-5 antibody formulation comprising an anti-IL-5 antibody having light chain of SEQ ID NO: 1 and heavy chain of SEQ ID NO: 2 at 50-150 mg/ml, 10-30 mM histidine, 75-130 mg/ml sucrose or 35-50 mg/ml sorbitol, and 0.1-0.4 mg/ml polysorbate 80 at pH 5.3-6.8.
Monck teaches a composition comprising an anti-IL-5 antibody at 76 mg/ml to 100 mg/ml [0244] and 10-30 mM histidine at pH 6.2-6.65, with pH 6.3 being preferred [0143], as in claims 1-2, 5, 21, 24, 33, and new claim 42. Monck teaches that the antibody concentration in the formulation is about 76 mg/ml to 100 mg/ml [0244], which overlaps with the antibody concentration ranges of instant claims 15, 21, and 24. Monck teaches a composition comprising an anti-IL-5 antibody having a heavy chain of SEQ ID NO: 1 and a light chain of SEQ ID NO: 2 [0005]; this antibody if mepolizumab [0042], as in instant claim 38. This antibody identical to the antibody of instant claims 1, 21, 24, 33 which is comprised of heavy chain of SEQ ID NO: 2 and light chain of SEQ ID NO: 1.
The composition of Monck may further comprise 5-20% weight by volume sucrose [0145], which reads on the sucrose limitation of instant claims 1, 8, 21, 24, and 33. When percentage is converted to weight by volume, 5-20% sucrose is 50-200 mg/ml sucrose, which overlaps with the sucrose concentration of 75-130 mg/ml of instant claims 1, 8, 21, 24, and 33.
The composition of Monck also comprises the surfactant polysorbate 80 [0146], as in instant claim 12. The concentration of polysorbate 80 is about 0.01-0.1% weight by volume [0146], which is the concentration 0.1-1 mg/ml, as in the polysorbate concentration of of 0.1-0.4 mg/ml of claims 1, 12, 21, 24, and 33.
Regarding claim 17, Monck teaches that the pharmaceutical composition may comprise 0.01-.1 mM EDTA [0105], which reads on the chelating agent of instant claim 17 and the EDTA limitation of new claim 44. When this concentration is converted to mg/ml, the range is 0.0037-0.037 mg/ml, which overlaps with the EDTA concentration of instant claims 17, 21, 24, and new claim 45.
With respect to instant claim 41, Monck teaches that the composition may be used to treat IL-5 mediated disease [0039]; the composition of Monck may be filled into containers [0244].
While Monck is silent regarding the stability of the formulation, as required by instant claim 38, it is clear that the same composition comprised of the same antibody and excipients at overlapping concentrations would have the same characteristics and effects as the instantly claimed composition since there is no evidence to the contrary. Note that rejections for anticipation or obviousness are appropriate when the prior art discloses a method (or product) that appears to be identical except that the art is silent as to an inherent property; see MPEP § 2112(III).
New claims 42-43 are drawn to the formulation of claim 1 wherein the pH is limited to pH 5.0, 6.0, 6.1, or 5.9-6.1. Monck does not include a composition for the anti-IL-5 antibody with pH range that overlaps with 5.9, 6.0, or 6.1; Monck teaches a composition of pH 6.2-6.65 [0143]. However, as stated in MPEP 2144.05(I), a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0). In the absence of any criticality regarding the new pH limitations of claims 42-43, the claims are obvious over the teachings of Monck.
Overall, the instant formulation comprises components that are routinely used and are at concentrations that are typical of those used in the art for preparation of liquid pharmaceutical antibody formulations. The art teaches a concentration that falls squarely within the claimed range, and there is no evidence of criticality in the instant specification. Therefore, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to select the recited carriers, excipients, surfactants, and stabilizers of Monck and to produce a stable pharmaceutical formulation of the anti-IL-5 antibody, also taught by Monck. One would have been motivated to select the excipients at the concentrations recited in view of the art-recognized need to optimize and stabilize formulations of therapeutic antibodies, and have a reasonable expectation of success, based on the knowledge and skill in the art and in view of the routine nature of the experimentation involved. Given that combination of the claimed components and the antibody pharmaceutical formulation had been previously described, without specific evidence in the specification that the indicated concentrations and pH are critical to the formulation, the identification of these properties do not render the subject matter patentable.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 5, 8, 12, 15, 17, 21, 24, 33, 35, 38, and 41 have been considered but are moot because the rejections under 35 U.S.C. 102(a)(1) and 102(a)(2) are withdrawn and the new ground of rejection under 35 U.S.C. 103 does not rely on any any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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