DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the AIA first to file provisions. 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 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.
Application Status
This action is responsive to the submission filed 12/23/2025.
Claims 1, 4-5, 7, 10, 12, 16, 19-22, 25, 27, and 30 are currently pending.
Information Disclosure Statement
The IDS filed on 2/27/2026 and 3/19/2026 have been considered. See the attached PTO 1449 forms.
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.
Claims 1, 5, 7, 27, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nishizawa US 2021/0229848.
Regarding claim 1:
Nishizawa teaches a method of filling a vial ([0156]), the method comprising: providing a pump (pumps A, B) corresponding to a vial; setting a no adjustment limit for a fill weight of the vial to T1, T1 being at or in a range of about 2% more or less than a fill weight of a target fill weight TO ([0156] discusses setting the fill amount to a target amount; e.g., 0.05 mL to 100 mL for a vial and/or a syringe); and filling the vial with a drug product via the pump (e.g., [0002]; claim 7), wherein the drug product has one or more of the following characteristics: (a) a density in a range of about 1.0-1.2 g/cm3; (b) a viscosity in a range of about 1.0-10.0 cP; and (c) a surface tension in a range of about 40.0 - 72.7 mN/m (e.g., see “Formulation B” in [0222]).
Regarding claim 5:
Nishizawa teaches the method of claim 1, as discussed above, wherein providing a pump corresponding to a vial comprises providing a fill set including a peristaltic pump filling assembly ([0271], [0272]) having a needle with an outer diameter of about 3.0mm ([0157], “2.6 mm to 3.6 mm” is interpreted as “about 3.0 mm”).
Regarding claim 7:
Nishizawa teaches the method of claim 1, as discussed above, wherein the drug product has a density in a range of about 1.0-1.2 g/cm3; a viscosity in a range of about 1.0-10.0 cP, and a surface tension in a range of about 40.0-- 72.7 mN/m (e.g., “Formulation B” in [0222]).
Regarding claim 27:
Nishizawa teaches a method of filling a vial, the method comprising: providing a pump corresponding to a vial (e.g., pumps A, B; [0271], [0272]); setting a no adjustment limit for a fill weight of the vial to any value within a range of a target fill weight TO and T1, with T1 being at or in a range between the target fill weight TO and T2 ([0156] discusses setting the fill amount to a target amount; e.g., 0.05 mL to 100 mL for a vial and/or a syringe), and filling the vial with a drug product via the pump (e.g., see [0276]-[0280]), wherein filling the vial with a drug product via the pump comprises filling the vial with a drug product including one or more of: (1) a density in a range of about 1.0-1.2 g/cm3; and/or (2) a viscosity in a range of about 1.0- 10.0 cP: and/or (3) a surface tension in a range of about 40.0-72.7 mN/m (e.g., see “Formulation B” in [0222]).
Regarding claim 30:
Nishizawa teaches the method of claim 27, as discussed above, wherein providing a pump corresponding to a vial comprises providing a fill set including a peristaltic pump filling assembly ([0271], [0272]) having a needle with an outer diameter of about 3.0mm ([0157], “2.6 mm to 3.6 mm” is interpreted as “about 3.0 mm”).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 4, 10, 12, 16, 19-22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Nishizawa, as applied above, and further in view of Husnu et al. US 2016/0199257.
Regarding claim 4:
Nishizawa teaches the method of claim 1, as discussed above, but does not teach wherein providing a pump corresponding to a vial comprises providing a pump corresponding to a vial of a nested syringe and vial line.
Husnu discloses a related filling method, teaching “Although described herein as having one pump 200 or one bulk product vial 100, for example, the system may encompass multiple pumps feeding multiple fluid pathways for dispensing multiple different products without cross contamination. The potential exposure of technicians may be further reduced, as the necessity to enter the shielded environment in order to change out disposable components of the system 10 between batches (radiation safety hazard) may be further reduced.” ([0084]).
It would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the method of Nishizawa, by providing a pump or multiple pumps corresponding to vials of a nested syringe and vial line, as taught by Husnu, since this would be useful in reducing associated operating safety hazards.
Regarding claim 10:
Nishizawa teaches a method of filling a plurality of vials, the method comprising: providing a plurality of pumps (e.g., pumps A, B; [0271], [0272]) corresponding to a plurality of vials; setting a no adjustment limit for a fill weight of each vial to T1, with T1 being at or in a range of about 2% more or less than a fill weight of a target fill weight TO ([0156] discusses setting the fill amount to a target amount; e.g., 0.05 mL to 100 mL for a vial and/or a syringe); and filling each vial of the plurality of vials with a drug product via a corresponding pump (e.g., see [0276]-[0280]), wherein the drug product has one or more of the following characteristics: (1) a density in a range of about 1.0-1.2 g/cm3; (2) a viscosity in a range of about 1.0-10.0 cP; and/or (3) a surface tension in a range of about 40.0-72.7 mN/m (e.g., see “Formulation B” in [0222]).
Nishizawa does not teach the vials being of a nested syringe and vial line.
Husnu discloses a related filling method, teaching “Although described herein as having one pump 200 or one bulk product vial 100, for example, the system may encompass multiple pumps feeding multiple fluid pathways for dispensing multiple different products without cross contamination. The potential exposure of technicians may be further reduced, as the necessity to enter the shielded environment in order to change out disposable components of the system 10 between batches (radiation safety hazard) may be further reduced.” ([0084]).
It would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the method of Nishizawa, by providing a pump or multiple pumps corresponding to vials of a nested syringe and vial line, as taught by Husnu, since this would be useful in reducing associated operating safety hazards.
Regarding claim 12:
The combination of Nishizawa and Husnu teaches the method of claim 10, as discussed above, wherein filling each vial of the plurality of vials with a drug product via a corresponding pump of the plurality of pumps comprises filling each vial of the plurality of vials with a monoclonal antibodies formulation drug product (Nishizawa, e.g., see “Formulation B” in [0222]).
Regarding claim 16:
The combination of Nishizawa and Husnu teaches the method of claim 10, as discussed above, wherein the drug product has a density in a range of about 1.0-1.2 g/cm3; a viscosity in a range of about 1.0-10.0 cP; and a surface tension in a range of about 40.0-72.7 mN/m (e.g., see “Formulation B” in [0222]).
Regarding claims 19 and 25:
Nishizawa teaches a method of optimizing a filling recipe, the method comprising: providing at least one pump (e.g., pumps A, B; [0271], [0272]) in an offline manufacturing system corresponding to at least one container ([0215]);
setting a no adjustment limit for a fill weight of the container to T1, with T1 being at or in a range of about 2% more or less than a fill weight of a target fill weight TO ([0156] discusses setting the fill amount to a target amount; e.g., 0.05 mL to 100 mL for a vial and/or a syringe);
filling the at least one container with a drug product having one or more of: (a) a density in a range of about 1.0-1.2 g/cm3; (b) a viscosity in a range of about 1.0-10.0 cP; and (c) a surface tension in a range of about 40.0-72.7 mN/m (e.g., see “Formulation B” in [0222]) via the at least one pump (e.g., see [0276]-[0280]); and finalizing a filling recipe using data from fill cycles of the drug product using the at least one pump in the offline manufacturing system ([0156] discusses finalized filling amount recipes for various vessels).
Nishizawa does not teach the vials being of a nested syringe and vial line, nor the dosing amount when the pump is started.
Husnu discloses a related filling method, teaching “Although described herein as having one pump 200 or one bulk product vial 100, for example, the system may encompass multiple pumps feeding multiple fluid pathways for dispensing multiple different products without cross contamination. The potential exposure of technicians may be further reduced, as the necessity to enter the shielded environment in order to change out disposable components of the system 10 between batches (radiation safety hazard) may be further reduced.” ([0084]).
It would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the method of Nishizawa, by providing a pump or multiple pumps corresponding to vials of a nested syringe and vial line, as taught by Husnu, since this would be useful in reducing associated operating safety hazards. It would have further been obvious to try, for a person having ordinary skill in the art, at the effective filing date of the invention, to modify the method of Nishizawa, by setting the start pump dosing to any desired amount, to find the optimal filling procedure for the vials.
Regarding claim 20:
The combination of Nishizawa and Husnu teaches the method of claim 19, as discussed above, further comprising monitoring a performance of the filling recipe in the nested syringe and vial line for the at least one container for each pump in a plurality of pumps in the nested syringe and vial line (Nishizawa, [0138] discusses monitoring performance and calibrating the filling recipe).
Regarding claim 21:
The combination of Nishizawa and Husnu teaches the method of claim 19, as discussed above, wherein the providing at least one pump in an offline manufacturing system corresponding to at least one container comprises providing a first fill set including a pump and a second fill set including a pump, each of the first and second fill sets in the offline manufacturing system, each of the first fill set and the second fill set having a corresponding filling container (i.e., each pump of Husnu can correspond to a fill set).
Regarding claim 22:
The combination of Nishizawa and Husnu teaches the method of claim 19, as discussed above, wherein the drug product includes a monoclonal antibodies (Nishizawa, [0222]).
Response to Arguments
Applicant’s remarks have been carefully considered but are not persuasive for the following reasons.
Regarding the limitation “setting a no adjustment limit for a fill weight of the vial to T1, with T1 being at or in a range of about 2% more or less than a fill weight of a target fill weight T0”, Applicant argues
“Nishizawa is completely silent regarding any no adjustment limit for a fill weight being at or in a range of 2% more or 2% less than a fill weight of a target fill weight. The Office action cites to paragraph [0156] of Nishizawa as allegedly disclosing such features, and in particular "setting the fill amount to a target amount; e.g., 0.05mL to 100mL for a vial and/or syringe." See Office action at page 3. However, generally stating only a fill amount is set to a target amount is not setting a no adjustment limit for a fill weight being at or in a range of about 2% more or less than a fill weight of the target fill weight, as recited in claim 1.”
Examiner respectfully disagrees. The limitation, present now in each independent claim, requires setting a fill weight of T1, with T1 being at or in a range of about 2% more or less than a fill weight of a target fill weight T0. Nishizawa discloses setting the fill weight, T1, to the target fill weight T0. T0 lies precisely in the center of the range of 0.98*T0 to 1.02*T0 (i.e., T1 is set to 1.0*T0), satisfying the claim language. As it stands currently, Examiner is interpreting the limitation “setting a no adjustment limit for a fill weight of the vial to T1, with T1 being at or in a range of about 2% more or less than a fill weight of a target fill weight T0” to be equivalent to “setting a fill weight of the vial to T1, with T1 being between 0.98 and 1.02 of a target fill weight T0”, which Nishizawa clearly discloses. It appears Applicant may be reading details not currently claimed into this limitation, in which case Examiner recommends incorporating any further limiting language into the claims themselves, in order to differentiate the claims from Nishizawa’s filling method.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 DARIUSH SEIF whose telephone number is (408) 918-7542. The examiner can normally be reached on Monday-Friday 9:30 AM-6:00 PM PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNA KINSAUL can be reached on 571-270-1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DARIUSH SEIF/Primary Examiner, Art Unit 3731