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 .
Status of Claims
This office action is responsive to claims filed on 02/21/2025.
Claims 1-5, and 8-20 are currently pending.
Cancellation of claims 6-7 are acknowledged.
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.
Claim 3 is 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 pre-AIA the applicant regards as the invention.
Regarding claim 3, the claim recites in part “the first handling device” in line 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, as best understood, the Office has interpreted the above recitation to read “the one or more handling devices” for purposes of proper antecedent basis and consistency.
Claim Rejections - 35 USC § 103
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.
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 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.
Claim 1-5, 11, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Broadbent et al. (US 20160200461 A1) in view of Trilli et al. (US 20180162572 A1), and in further view of Kluetsch et al. (US 20100070108 A1).
Regarding claim 1, Broadbent discloses a method of filling a container with a liquid in a filling module of an isolator system (10), the method comprising the steps of:
- arranging the container (90) to be filled in a first transfer station (30) for transferring the container (90) into the filling module (20; [0045]-[0050]);
- first transferring of the container (90) from the first transfer station (30) to a filling station (60) of the filling module (Fig. 1) by means of one or more handling devices (22) of a plurality of handling devices (22; [0015]-[0016], and [0057]; multiple articulated arms) of the filling module (Fig. 1);
- filling the container (90) with the liquid in the filling station ([0014]; “filling the first plurality of containers with the pharmaceutical product in the first controlled environment enclosure”);
- second transferring of the filled container (90) from the filling station (60) to a stopper placing station (40) of the filling module (Fig. 1) by means of one or more handling devices of the plurality of handling devices (22);
- placing a stopper (120) on the filled container (90) in the stopper placing station (40); and
- third transferring of the filled container (90) from the stopper placing station (40) to a second transfer station for transferring the filled container (90) from the filling module by means of one or more handling devices of the plurality of handling devices ([0064]; “the articulated arm apparatus 22 may move the filled, stoppered, and capped nest 70 with containers 90 to an adjacent controlled environment enclosure (not shown) through a suitable communicating door (not shown)”);
- closing the filled container (via capping-[0064]-[0066]); and
- transferring the filled container between modules via a transferring module (via nest 70 and 22; Fig. 1).
However, Broadbent is silent with regards to crimping module.
Trilli in a related invention teaches that it is old and well known in the relevant art to provide a crimping module (3, 10)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Broadbent by incorporating a crimping module as taught by Trilli in order to lock a closure stopper and form a closing seal ([0010] and [0044] of Trilli).
However, Broadbent as modified teaches lyophilization (Freeze-drying) of the containers is silent with regards to a freeze-drying module.
Kluetsch in a related invention teaches that it is old and well known in the relevant art to provide a freeze-drying module (12; [0002], [0007], and [0021]) including a transfer means (10) for transferring containers to the freeze drying module (12).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Broadbent as modified by incorporating a freeze-drying module with automated transfer as taught by Kluetsch in order to enhancing product stability, extending shelf life, and preserving biological products used in pharmaceutical industry. Adding a freeze-drying module with transfer means is a routine improvement to increase throughput and capacity, and higher efficiency aseptic fill-finish with integrated freeze-drying.
Broadbent as modified further teaches:
Regarding claim 2, Broadbent discloses essentially the claimed method according to claim 1 including the filling station (60 of Broadbent) but is silent regarding wherein the filling station comprises a weighing device for weighing the container, the method further comprising the steps of:- first weighing of the container before filling the container by means of the weighing device; and/or - second weighing of the filled container after filling the container by means of the weighing device.
Trilli in a related invention teaches the filling station comprises a weighing device (15) for weighing the container, the method further comprising the steps of:- first weighing of the container before filling the container by means of the weighing device ([0045]); and/or - second weighing of the filled container after filling the container by means of the weighing device ([0046]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Broadbent by incorporating a weighing device as taught by Trilli in order to verify exact weight of container before and after filling and verify its correspondence to the preset standards ([0045]-[0046]).
Regarding claim 3, wherein the container (90 of Broadbent) is placed on weighing device (15 of Trilli) for weighing before filling and/or after filling by means of the first handling device (22 of Broadnet as modified). Trilli further teaches positioning the container on a weighing device by means of the first handling device (6). it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Broadbent by incorporating positioning the container on a weighing device by means of the first handling device as taught by Trilli in order to verify exact weight of container before and/or after filling.
Regarding claim 4, wherein the weighing device (15 of Broadbent) is arranged below a filling needle (Fig. 9 of Triller as modified).
Regarding claim 5, wherein the method further comprises the step of: removal of the container to be filled from a nest (Fig. 2 of Broadbent) by means of a removal module (34 and/or a robotic articulated arm of Broadbent [0043]). Trilli further teaches removal of the container to be filled from a nest (Fig. 1) by means of a removal module (14 and/or 6). it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Broadbent by incorporating additional removal module as taught by Trilli in order to leverage existing robotic control for automated and efficient process and transport which is a predictable improvement with no unexpected results.
Regarding claim 11, wherein the method further comprises the step of. freeze-drying of the filled container by means of the freeze-drying module (12 of Kluetsch).
Regarding claim 14, Broadbent discloses the transfer stations and receptacles (80) and removing the container to be filled from the receptacle of the first transfer station (30) by means of the first handling device (arm 22) but is silent regarding the method further comprising the step of:- inserting the filled container into the receptacle of the second transfer station by means of the second handling device.
Trilli in a related invention teaches inserting the filled container (A) into the receptacle (D, 19) of the second transfer station (3) by means of the second handling device (9) .
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Broadbent by incorporating inserting the filled container into the receptacle of the second transfer station by means of the second handling device as taught by Trilli in order to prevent any possible contamination of the containers and of their contents, thus obtaining a sealed container that is free from contamination.
Claim 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Broadbent et al. (US 20160200461 A1) in view of Trilli et al. (US 20180162572 A1) and Kluetsch et al. (US 20100070108 A1), and in further view of Bechini et al. (EP 3335844 priority filing date is relied upon for rejection however US 20190315004 A1 used herein for rejection), and in further view of IMA Pharma brochure entitled “Aseptic Processing & Freeze Drying Solutions” (November 2015, hereinafter “IMA Hydra Brochure” https://www.pharmacompass.com/pdf/party/content/ima-pharma-party-content-1487755072.pdf), which discloses the HYDRA 100/300 series external vial washers.
Regarding claim 8, Broadbent as modified discloses a method of filling a container with a liquid in a filling module of an isolator according to claim 1.
However, Broadbent as modified does not disclose external washing of the sealed container by means of an external washing module.
Bechini teaches that it is old and well known to provide external washing of the container by means of an external washing module ([0071] and [0078]-[0079]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Broadbent as modified by incorporating an external washing module as taught by Bechini in order to further clean the containers ([0071] of Bechini).
Broadbent as modified is silent regarding the washing module for washing sealed containers.
IMA Hydra Brochure teaches that it is old and well known to provide external washing of sealed container by means of an external washing module (IMA Hydra Brochure on page 5 teaches “The importance of decontaminating the filled and capped vials coming out from a processing line is becoming increasingly popular in the world of sterile applications. The possibility to reduce or even avoid cross contamination of vials is satisfied with the external washers of the HYDRA 100/300 Series. From 2 to 500 ml vial, Up to 18,000 vials/hour, Quick and easy size change over, Automatic drainage and drying system”).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Broadbent as modified by incorporating an external washing module for washing sealed containers as taught by IMA Hydra Brochure in order to further decontaminate, reduce or even avoid cross contamination of vials containers (Page 5 of IMA Brochre).
Regarding claim 9, further comprising the step of:- individually removing of the container after external washing (via robotic transfers and re-nesting of Broadbent as modified).
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Broadbent et al. (US 20160200461 A1) in view of Trilli et al. (US 20180162572 A1), in further view of Bechini et al. (EP 3335844 priority filing date is relied upon for rejection however US 20190315004 A1 used herein for rejection), in further view of IMA Pharma brochure entitled “Aseptic Processing & Freeze Drying Solutions” (November 2015, hereinafter “IMA Hydra Brochure”; Link https://www.pharmacompass.com/pdf/party/content/ima-pharma-party-content-1487755072.pdf), which discloses the HYDRA 100/300 series external vial washers, in further view of Veile (US 9796489 B2).
Regarding claim 10, Broadbent discloses a method of filling a container with a liquid in a filling module of an isolator system (10), the method comprising the steps of:
- arranging the container (90) to be filled in a first transfer station (30) for transferring the container (90) into the filling module (20; [0045]-[0050]);
- first transferring of the container (90) from the first transfer station (30) to a filling station (60) of the filling module (Fig. 1) by means of one or more handling devices (22) of a plurality of handling devices (22; [0015]-[0016], and [0057]; multiple articulated arms) of the filling module (Fig. 1);
- filling the container (90) with the liquid in the filling station ([0014]; “filling the first plurality of containers with the pharmaceutical product in the first controlled environment enclosure”);
- second transferring of the filled container (90) from the filling station (60) to a stopper placing station (40) of the filling module (Fig. 1) by means of one or more handling devices of the plurality of handling devices (22);
- placing a stopper (120) on the filled container (90) in the stopper placing station (40); and
- third transferring of the filled container (90) from the stopper placing station (40) to a second transfer station for transferring the filled container (90) from the filling module by means of one or more handling devices of the plurality of handling devices ([0064]; “the articulated arm apparatus 22 may move the filled, stoppered, and capped nest 70 with containers 90 to an adjacent controlled environment enclosure (not shown) through a suitable communicating door (not shown)”);
- closing the filled container (via capping-[0064]-[0066]);
wherein the container (90) is transferred back to a removal module (via 34 and robotic arms) after filling and stopper placing in the filling module ([0064]) or after capping in the crimping module or after external washing in the external washing module through the individual modules,
However, Broadbent is silent with regards to crimping module.
Trilli in a related invention teaches that it is old and well known in the relevant art to provide a crimping module (3, 10)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Broadbent by incorporating a crimping module as taught by Trilli in order to lock a closure stopper and form a closing seal ([0010] and [0044] of Trilli).
However, Broadbent as modified does not disclose external washing of the container by means of an external washing module.
Bechini teaches that it is old and well known to provide external washing of the container by means of an external washing module ([0071] and [0078]-[0079]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Broadbent as modified by incorporating an external washing module as taught by Bechini in order to further clean the containers ([0071] of Bechini).
Broadbent as modified is silent regarding the washing module for washing sealed containers.
IMA Hydra Brochure teaches that it is old and well known to provide external washing of sealed container by means of an external washing module (IMA Hydra Brochure on page 5 teaches “The importance of decontaminating the filled and capped vials coming out from a processing line is becoming increasingly popular in the world of sterile applications. The possibility to reduce or even avoid cross contamination of vials is satisfied with the external washers of the HYDRA 100/300 Series. From 2 to 500 ml vial, Up to 18,000 vials/hour, Quick and easy size change over, Automatic drainage and drying system”).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Broadbent as modified by incorporating an external washing module for washing sealed containers as taught by IMA Hydra Brochure in order to further decontaminate, reduce or even avoid cross contamination of vials containers (Page 5 of IMA Brochre).
Broadbent as modified is further silent regarding returning the container to a nest from which it was removed and wherein the removal module is configured to place the container back into the nest from which it was removed..
Veile in a related invention teaches that it is old and well known to return a container to a nest from which it was removed (Col 1 lines 20-40, Col 2 lines 32-41) and wherein the removal module is configured to place the container back into the nest from which it was removed.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Broadbent as modified by incorporating returning the container to a nest from which it was removed as taught by Veile in order to reduce excessive handling that can damage delicate pharmaceutical objects. The combination only requires routine engineering by applying the know de-nest process-re-nest process sequence to the robotic handling and transfer stations already present for desirable feature of efficiency and gentle handling. Note Broadbent already teaches the removal module, the combination will simply place the container back into the nest (re-nesting via Veile).
Claims 15-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bechini et al. (EP 3335844 priority filing date is relied upon for rejection however US 20190315004 A1 used herein for rejection) in view of Diaz (US 20190337658 A1).
Regarding claim 15, Bechini discloses a method of filling a container (70) with a liquid in a filling module of an isolator system (9; and Figs. 7A-7C), the method comprising the steps of:
arranging the container (70) to be filled in a first transfer station (917) for transferring the container into the filling module (3; Fig. 7C);
first transferring the container from the first transfer station (917) to a filling station of the filling module (3) by means of a first handling device 1, 2) of the filling module (3);
filling the container (70) with the liquid in the filling station (30); and
moving the container (70) relative to the filling station (Fig. 7A) by means of the first handling device (1) while the container is being filled ([0083]).
Bechini is silent regarding filling station having filling needle and moving the container relative to the filling needle.
Diaz teaches that it is old and well known to provide filling station having filling needle (62; [0018]) and moving the container relative to the filling needle ([0078]-[0079]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have modified the method of Bechini as modified by filling needle as taught by Diaz. Doing so ensures dispensing accurate amount of liquid into the containers.
Regarding claim 16, wherein the filling needle is inserted into the container through an opening of the container for filling ([0079]-[0080] of Diaz).
Regarding claim 18, wherein the filling module further comprises a stopper placing station (@220) for placing a stopper (71) on the filled container ([0083] of Bechini).
Regarding claim 19, further comprising the steps of: second transferring of the container from the filling station to a stopper placing station (@220) of the filling module (3) by means of the first handling device and/or a second handling device (1, 2); and placing a stopper on the container in the stopper placing station (@220 Bechini).
Regarding claim 20, wherein the method further comprises the step of: third transferring of the container from the stopper placing station to a second transfer station (919 Bechini) for transferring the container from the filling module (3 Bechini) by means of the second handling device (2 Bechini).
Allowable Subject Matter
Claims 12-13 and 17 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.
Response to Arguments
Applicant’s arguments with respect to claims 1-5, and 8-20 have been considered but are moot because the arguments do not apply to any of the combination of references being used in the current rejection.
Conclusion
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 NICHOLAS E IGBOKWE whose telephone number is (571)272-1124. The examiner can normally be reached on M-F 8 a.m. - 5 p.m..
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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.
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/NICHOLAS E IGBOKWE/Examiner, Art Unit 3731
/ANDREW M TECCO/Primary Examiner, Art Unit 3731