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 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 (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 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.
Claim(s) 1 - 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Papciak et al. (5447699) in view of Steffen et al. (6254330).
Regarding claim 1, the Papciak et al. reference discloses a system for aseptically transferring components into a pharmaceutical isolator (16; Figure 1), the system comprising:
a transfer table having a table surface for supporting a bag containing the components;
a clamping bar (130) movably mounted to clamp down onto the bag; and
a decontamination connector (14) that is mountable in front of a filling port of the isolator: wherein the decontamination connector includes a spray nozzle that contains a decontamination agent and that opens into an interior space of the decontamination connector (see col. 2, lines 28-34). The Papciak et al. reference doesn’t disclose a transfer table being placed in front of the filling port of the isolator, such that a front end of the table surface is close to the filling port and a back end thereof is remote from the filling port: the clamping bar being movably mounted on the transfer table.
The Steffen et al. reference discloses another transfer system having a transfer table (227) being placed in front of the filling port (106) of the isolator, such that a front end of the table surface is close to the filling port and a back end thereof is remote from the filling port (see Figures 7 and 8; col. 6, line 54 – col. 7, line 6): a clamping bar (i.e., a pneumatic latch; col. 7, lines 31-46) movably mounted on the transfer table. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify the Papciak et al. device to have a transfer table as, for example, taught by the Steffen et al. reference in order to aid in lifting and transferring material.
Regarding claim 2, the Steffen et al. reference further teaches a tilt mechanism (200) that is mounted on a frame that supports the transfer table and that allows the table surface to be selectively tilted between a horizontal position and a tilt position that creates an inclined surface down toward the front end of the table (see col. 7, lines 16-24).
Regarding claim 3, modified Papciak et al. discloses the invention (discussed supra), but doesn’t disclose a retainer bar that is movably mounted on the back end of the table so as to selectively hold a portion of the component section of the bag against the table. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide an additional retainer bar at the back end of the table, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Papciak et al. (5447699), as applied to claim 1, and further in view of Wang et al. (6581435).
Regarding claim 8, modified Papciak et al. disclose the invention (discussed supra), but doesn’t disclose a pressure sensor for sensing a prevailing pressure inside the decontamination connector; wherein the pressure sensor is linked to an electronic control and, while sensing the prevailing pressure, signals a drop in pressure if such does occur. The Wang et al. reference discloses a system having multiple sensors to monitor conditions within a pharmaceutical isolator (col. 14, lines 27-34) including a pressure sensor (116) to monitor pressure in a test chamber (108). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify the Papciak et al. device to have a pressure sensor as, for example, taught by the Wang et al. reference in order to control the pressure within the system.
Allowable Subject Matter
Claims 4 – 7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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: None of the prior art of record, alone or in combination, teach:
Regarding claim 4, a ring seal on an outer circumference of the decontamination connector; and a clamping ring that is mounted on the decontamination connector and that is movable between a release position and a clamping position;
wherein, after the front section of the bag has been pushed over the ring seal and the decontamination connector, the clamping ring is movable into the clamping position, thereby holding the bag against the decontamination connector in a gas-tight manner.
Claim 5 is dependent upon claim 4.
Regarding claim 6, a cutter bar that is mounted on the front end of the transfer table and that is movable so as to cut across the bag to open the front end of the bag.
Claim 7 is dependent upon claim 6.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The Milla et al. (2023/0365282) reference discloses a high-pressure processing transfer system and tilting table (Figure 17).
The Bonerb (5685454) reference discloses another bag transfer system with tilting table (Figure 1).
The Nagler et al. (12420972) reference discloses a system for transferring material through an isolator with a tilting table (Figure 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY LEWIS MAUST whose telephone number is (571)272-4891. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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, Craig Schneider can be reached at 571-272-3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TIMOTHY L MAUST/ Primary Examiner, Art Unit 3753
Prosecution Insights