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 .
Election/Restrictions
Applicant’s election without traverse of species A (amorphous carbon coating, silicon carbide), species B (drug layer composition, SiOxCy), species C (vessel wall, COP), and species D (polysorbate, polysorbate 80) in the reply filed on 4/3/2026 is acknowledged.
Claims 11, 14, and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species A, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/3/2026.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species B, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/3/2026.
Claim 38 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species C, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/3/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 3, 262, 260, 216, 258, 256; Figure 4, 262, 224, 226, 216; Figure 5, 216, 224, 226. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 3, 5-6, 8, 17, 35-37, 40, 42-43, 45-48 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 3 recites the limitation "concentration of polysorbate”. There is insufficient antecedent basis for this limitation in the claim. It is not clear if this refers to “polysorbate stabilizer” or a different polysorbate. Claims 5-6, 8, 17, 35-37, 40, 42-43, 45-48 are rejected as well since they depend on claim 3 and do not correct the issue.
Claims 5 and 8 recite the limitation "the aqueous drug product or drug-containing solution”. There is insufficient antecedent basis for this limitation in the claim. This term has not previously been claimed.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “a pH between 5 and 9”, and the claim also recites “between 5 and 8” and “between 5 and 7” which are narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 17 recites the broad recitation “thickness of 10 to 1000 nm”, and the claim also recites “10 to 500 nm”, “10 to 200 nm”, and “20 to 100 nm” which are narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 42 recites the broad recitation “at least 1 month”, and the claim also recites “at least two months…6 months” which are narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claims 8, 17, 35, 42, 45, 46, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 43 recites the limitation "the polysorbate”. There is insufficient antecedent basis for this limitation in the claim. It is not clear if this refers to “polysorbate stabilizer” or a different polysorbate.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 3, 5-6, 8, 17, 35-37, 40, 42-43, 45-48 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by WO2014/008138 by Weikart et al. (Weikart).
In regard to claim 3, Weikart teaches a method of reducing the polysorbate concentration of a drug-containing solution within a drug primary package ([04]-[05], [204]-[211]; claims 1, 3, 82-83, 94-95, 102-103, 126-174, 217, 297, 328, 1404). Weikart teaches providing a vessel having a lumen defined at least in part by a wall ([204]-[211]). Weikart teaches the wall having an interior surface facing the lumen ([204]-[211]). Weikart teaches the interior surface comprising a coating that is free or substantially free of metal ions ([204]-[211]; [08]; [301]).
Weikart teaches storing a drug-containing solution in the lumen of the vessel ([204]-[211]), such that the drug-containing solution is in contact with the coating ([204]-[211]). Weikart teaches the drug-containing solution comprises a polysorbate stabilizer and the coating is effective to reduce degradation of the polysorbate stabilizer in the solution during storage ([204]-[211], [254]). Weikart teaches a concentration of polysorbate in the drug-containing solution is reduced relative to that of the same drug-containing solution formulated for the same vessel but without the coating and/or that of the same drug-containing solution formulated for storage in a glass vessel ([204]-[211]; [306]-[310], [409]).
In regard to claim 5, Weikart teaches the coating is configured so that leaching of metal ions into the aqueous drug product or drug-containing solution from the vessel is avoided ([06]-[09], [90], [130], [187], [301]).
In regard to claim 6, Weikart teaches the coating is configured to withstand dissolution by aqueous drug products or drug-containing solutions having a pH between 2 and 9 ([204]-[211]; claims 142-148).
In regard to claim 8, Weikart teaches the aqueous drug product or drug-containing solution has a pH between 5 and 9 ([204]-[211]).
In regard to claim 17, Weikart teaches the coating has a thickness of 10 to 1000 nm ([220]).
In regard to claim 35, Weikart teaches the vessel wall is a thermoplastic material ([204]-[213]).
In regard to claim 36, Weikart teaches the vessel wall is a COP ([213]).
In regard to claim 37, Weikart teaches the vessel wall is a cyclic olefin polymer (COP) ([213]).
In regard to claim 40, Weikart teaches the vessel is a syringe or a vial ([212]).
In regard to claim 42, Weikart teaches the storing takes place for at least one month ([84]; [257]).
In regard to claim 43, Weikart teaches the polysorbate is polysorbate 80 or 20 ([254]).
In regard to claim 45, Weikart teaches the drug-containing solution comprises a protein-based drug ([234]).
In regard to claim 46, Weikart teaches the drug-containing solution comprises a vaccine ([234]).
In regard to claim 47, Weikart teaches the drug-containing solution comprises a radioisotope ([234]).
In regard to claim 48, Weikart teaches a drug-containing solution is a biologic drug product comprising a peptide active agent ([234]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA M PEO whose telephone number is (571)272-9958. The examiner can normally be reached 9 to 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vickie Kim can be reached at 571-272-0579. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA M PEO/Primary Examiner, Art Unit 1774
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