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 Objections
Claim 1 is objected to because of the following informalities:
Claim 1, ln. 6 should read ---to form [[a]] the first bag;---
Appropriate correction is required.
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.
Claim(s) 1, 4, 8, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trouilly et al. (Pub. No.: US 2007/0031976 A1) in view of Di Naro (Pub. No.: US 2019/0142694 A1).
Regarding claim 1, Trouilly discloses (fig. 1-2) a method of manufacturing an “all-in-one” parenteral nutrition system (¶ 0002), the method comprising:
Producing a flexible multi-chamber bag (container 10), wherein producing the flexible multi-chamber bag comprises:
Non-peelably sealing a top edge (32), a bottom edge (34), a left edge (20) and a right edge (18) of two polymer films to form the first bag (¶ 0065);
Peelably sealing a first peelably sealing wall (openable seal 22) and a second peelably sealing wall (openable seal 24) between the two polymer films separating the first bag into a first chamber (14) between the first peelably sealing wall and the second peelably sealing wall (fig. 1, ¶ 0042);
A second chamber (12);
A third chamber (16);
The flexible multi-chamber bag comprising:
The first chamber comprising a first port tube (28, ¶ 0043);
The second chamber comprising a second port tube (26, ¶ 0043);
The third chamber comprising a third port tube (30);
The method further comprising:
Adding an amino acids solution into the first chamber through the first port tube (¶ 0109, ¶ 0043);
Adding a glucose solution into the second chamber through the second port tube (¶ 0109, ¶ 0043); and
Adding a lipid emulsion into the third chamber through the third port tube (¶ 0109, ¶ 0043).
Trouilly fails to disclose peelably sealing a third peelably sealing wall extending from the left edge to the first peelably sealing wall to form a fourth chamber; peelably sealing a fourth peelably sealing wall extending from the right edge to the second peelably sealing wall to form a fifth chamber; the fourth chamber including a fourth port tube; and the fifth chamber comprising a fifth port tube; adding a vitamin solution or emulsion into the fourth chamber through the fourth port tube; adding a trace elements solution into the fifth chamber through the fifth port tube; and sealing the first port tube, the second port tube, the third port tube, the fourth port tube and the fifth port tube.
Di Naro teaches (fig. 10) a method of manufacturing a system (abstract) and thus in the same field of endeavor, comprising: producing a flexible multi-chamber bag (100), wherein producing the multi-chamber bag comprises:
Peelably sealing a peelably sealing wall (seal 130 which may extend the length of the bag, ¶ 0033) Peelably sealing an additional wall (second breakable seal 170) extending from an edge to the peelably sealing wall (breakable seal 130) to form a chamber (160) and an additional chamber (110) (fig. 10, ¶ 0054), each chamber comprising a port tube (120, 122) (fig. 10); adding a solution to each chamber through the port tubes (¶ 0032); and sealing the port tubes (¶ 0040), the additional peelably sealing wall configured to form the chamber and additional chamber configured to hold another pharmaceutical product (¶ 0054); and sealing the port tubes to enable attachment of equipment for introducing solutions into the chambers and for extracting solutions form the chambers (¶ 0040).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Trouilly such that it comprises: peelably sealing a third peelably sealing wall extending from the left edge to the first peelably sealing wall to form a fourth chamber; peelably sealing a fourth peelably sealing wall extending from the right edge to the second peelably sealing wall to form a fifth chamber; the fourth chamber including a fourth port tube; and the fifth chamber comprising a fifth port tube, and sealing the port tubes, as suggested by Di Naro, in order to provide additional chambers configured to hold pharmaceutical products (Di Naro ¶ 0054) and enable attachment of equipment for introducing solutions into the chambers and for extracting solutions form the chambers (Di Naro ¶ 0040).
Further, Trouilly discloses that a vitamin solution and a trace elements solution are components of a parenteral nutritional solution (¶ 0008).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Trouilly in view of Di Naro such that it includes adding a vitamin solution or emulsion into the fourth chamber through the fourth port tube; adding a trace elements solution into the fifth chamber through the fifth port tube as such components are generally components of a parenteral nutritional solution (Trouilly ¶ 0008).
Regarding claim 4, Trouilly in view of Di Naro disclose wherein producing the flexible multi-chamber bag further comprises non-peelably sealing the first port tube, the second port tube and the third port tube at the top edge (Trouilly, ¶ 0065).
Regarding claim 8, Trouilly in view of Di Naro disclose wherein producing the flexible multi-chamber bag further comprises non-peelably sealing the fourth port tube and the fifth port tube at the bottom edge (Trouilly, ¶ 0065).
Regarding claim 19, Trouilly in view of Di Naro fail to disclose connecting an administration port to the first chamber at the bottom edge.
Di Naro teaches (fig. 1) connecting an administration port (port 124) to a first chamber (120) at the bottom edge (fig. 1, ¶ 0032), in order to provide a port for administering the pharmaceutical product to a patient (¶ 0032).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first chamber of Trouilly in view of Di Naro such that it includes an administration port at the bottom edge, as taught by Di Naro, in order to provide a port for administering the pharmaceutical product to a patient (Di Naro, ¶ 0032).
Regarding claim 20, Trouilly in view of Di Naro fail to disclose connecting a medication port to the first chamber at the bottom edge.
Di Naro teaches (fig. 1) connecting an medication port (port 12) to a first chamber (120) at the bottom edge (fig. 1, ¶ 0032), in order to provide a port for introducing a reconstituting solution in a sterile manner (¶ 0032).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first chamber of Trouilly in view of Di Naro such that it includes an medication port at the bottom edge, as taught by Di Naro, in order to provide a port for introducing a reconstituting solution in a sterile manner (Di Naro ¶ 0032).
Claim(s) 2-3, 5-7, and 9-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trouilly in view of Di Naro, as applied to claims 1, 4, and 8 above, and further in view of Pittet et al. (Pub. No.: US 2013/0046271 A1).
Regarding clam 2, Trouilly in view of Di Naro fail to disclose sealing portions comprising the first port tube, the second port tube, the third port tube, the fourth port tube, and the fifth port tube.
Pittet teaches (fig. 1-3) a method of manufacturing an “all-in-one” parenteral nutrition system (resultant multiple chamber bag 10, fig. 3, ¶ 0041) and thus in the same field of endeavor, comprising sealing portions comprising port tubes (22, 23, 24) (¶ 0031) in order to provide a liquid tight bag (¶ 0031).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Trouilly in view of Di Naro such that it includes sealing portions comprising the first port tube, the second port tube, the third port tube, the fourth port tube, and the fifth port tube, as taught by Pittet, in order to provide a liquid tight bag (Pittet ¶ 0031).
Regarding claim 3, Trouilly in view of Di Naro and further in view of Pittet fail to disclose the method further comprising cutting and removing portions comprising the first port tube, the second port tube, the third port tube, the fourth port tube and the fifth port tube from the flexible multi-chamber bag to form the “all-in-one” parenteral nutrition system.
Pittet further teaches (fig. 1-3) the method comprising producing a flexible multi-chamber bag (multichamber bag 10, fig. 1); and cutting and removing portions comprising the port tubes from the flexible multi-chamber bag to form the “all-in-one” parenteral nutrition system (fig. 3, ¶ 0032) in order to prevent the risk of unintended damage of the “all-in-one” parenteral nutrition system from the ports (¶ 0006).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Trouilly in view of Di Naro such that it includes cutting and removing portions comprising the first port tube, the second port tube, the third port tube, the fourth port tube and the fifth port tube from the flexible multi-chamber bag to form the “all-in-one” parenteral nutrition system, as taught by Pittet, in order to prevent the risk of unintended damage of the “all-in-one” parenteral nutrition system from the ports (Pittet ¶ 0006).
Regarding claim 5, Trouilly in view of Di Naro fail to disclose wherein the sealing the first port tube, the second port tube, and the third port tube comprises non-peelably sealing a first non-peelably sealing wall near the top edge to form a portion comprising the first port tube, the second tube, and the third port tube.
Pittet teaches (fig. 1-3) a method of manufacturing an “all-in-one” parenteral nutrition system (resultant multiple chamber bag 10, fig. 3, ¶ 0041) and thus in the same field of endeavor, comprising non-peelably sealing a first non-peelably sealing wall near an edge to form a portion comprising port tubes (22, 23, 24) (¶ 0031) in order to provide a liquid tight bag (¶ 0031).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Trouilly in view of Di Naro such that sealing the first port tube, the second port tube, and the third port tube comprises non-peelably sealing a first non-peelably sealing wall near the top edge to form a portion comprising the first port tube, the second tube, and the third port tube, as taught by Pittet, in order to provide a liquid tight bag (Pittet ¶ 0031).
Regarding claim 6, Trouilly in view of Di Naro and further in view of Pittet disclose wherein the first non-peelably sealing wall extends from the left edge to the right edge (Trouilly, see end 32).
Regarding claim 7, Trouilly in view of Di Naro and further in view of Pittet fail to disclose cutting and removing the portion comprising the first port tube, the second port tube and the third port tube.
Pittet further teaches (fig. 1-3) cutting and removing portions comprising the port tubes (fig. 3, ¶ 0032) in order to prevent the risk of unintended damage of the “all-in-one” parenteral nutrition system from the ports (¶ 0006).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Trouilly in view of Di Naro such that it includes cutting and removing portions comprising the first port tube, the second port tube, and the third port tube, as taught by Pittet, in order to prevent the risk of unintended damage of the “all-in-one” parenteral nutrition system from the ports (Pittet ¶ 0006).
Regarding claim 9¸ Trouilly discloses wherein sealing the fourth port tube comprises non-peelably sealing a second non-peelably sealing wall (see border 40) (Trouilly, fig. 1). Trouilly in view Di Naro fail to disclose sealing the second non-peelably sealing wall to form a portion comprising the fourth port tube.
Pittet teaches (fig. 1-3) a method of manufacturing an “all-in-one” parenteral nutrition system (resultant multiple chamber bag 10, fig. 3, ¶ 0041) and thus in the same field of endeavor, comprising sealing a non-peelably sealing wall to form a portion comprising port tubes (22, 23, 24) (¶ 0031) in order to provide a liquid tight bag (¶ 0031).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Trouilly in view of Di Naro such that it includes sealing the second non-peelably sealing wall forms a portion comprising the fourth port tube, as taught by Pittet, in order to provide a liquid tight bag (Pittet ¶ 0031).
Regarding claim 10, Trouilly in view of Di Naro and further in view of Pittet disclose wherein the second non-peelably sealing wall extends from the left edge to the bottom wall (Trouilly fig. 1, see border 40).
Regarding claim 11, Trouilly in view of Di Naro and further in view of Pittet disclose wherein a portion of the second non-peelably sealing wall extends from the left edge downward to the first peelably sealing wall (Trouilly fig. 1, see border 40 adjacent seal 22).
Regarding claim 12, Trouilly in view of Di Naro and further in view of Pittet fail to disclose cutting and removing the portion comprising the fourth port tube.
Pittet further teaches (fig. 1-3) cutting and removing the portion comprising the port tubes (fig. 3, ¶ 0032) in order to prevent the risk of unintended damage of the “all-in-one” parenteral nutrition system from the ports (¶ 0006).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Trouilly in view of Di Naro such that it includes cutting and removing the portion comprising the fourth port tube, as taught by Pittet, in order to prevent the risk of unintended damage of the “all-in-one” parenteral nutrition system from the ports (Pittet ¶ 0006).
Regarding claim 13, Trouilly in view of Di Naro disclose wherein sealing the fifth port tube comprises non-peelably sealing a third non-peelably sealing wall (see border 40). Trouilly in view Di Naro fail to disclose sealing the third non-peelably sealing wall to form a portion comprising the fifth port tube.
Pittet teaches (fig. 1-3) a method of manufacturing an “all-in-one” parenteral nutrition system (resultant multiple chamber bag 10, fig. 3, ¶ 0041) and thus in the same field of endeavor, comprising sealing a non-peelably sealing wall to form a portion comprising port tubes (22, 23, 24) (¶ 0031) in order to provide a liquid tight bag (¶ 0031).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Trouilly in view of Di Naro such that it includes sealing the third non-peelably sealing wall forms a portion comprising the fifth port tube, as taught by Pittet, in order to provide a liquid tight bag (Pittet ¶ 0031).
Regarding claim 14, Trouilly in view of Di Naro disclose wherein the third non-peelably sealing wall extends from the second edge to the bottom wall (Trouilly fig. 1, see border 40).
Regarding claim 15, Trouilly in view of Di Naro disclose wherein a portion of the third non-peelably sealing wall extends from the right edge downward to the second peelably sealing wall (Trouilly fig. 1, see border 40 adjacent seal 24).
Regarding claim 16, Trouilly in view of Di Naro and further in view of Pittet fail to disclose cutting and removing the portion comprising the fifth port tube.
Pittet further teaches (fig. 1-3) cutting and removing the portion comprising the port tubes (fig. 3, ¶ 0032) in order to prevent the risk of unintended damage of the “all-in-one” parenteral nutrition system from the ports (¶ 0006).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Trouilly in view of Di Naro such that it includes cutting and removing the portion comprising the fifth port tube, as taught by Pittet, in order to prevent the risk of unintended damage of the “all-in-one” parenteral nutrition system from the ports (Pittet ¶ 0006).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trouilly in view of Di Naro, as applied to claim 1 above, and further in view of Schroder (Pub. No.: US 2010/0318058 A1).
Regarding claim 17, Trouilly in view of Di Naro fail to disclose wherein the peelably sealing the third peelably sealing wall comprises: peelably sealing a fifth peelably sealing wall starting from an inner surface of the left edge; and peelably sealing a sixth peelably sealing wall starting from the first peelably sealing wall, wherein both the fifth peelably sealing wall and the sixth peelably sealing wall connect at a first connection point to form the third peelably sealing wall.
Schroder teaches (fig. 1a) a method of manufacturing a system, the method comprising: producing a flexible multi-chamber bag (1) and thus in the same field of endeavor, wherein peelably sealing a third peelably sealing wall comprises: peelably sealing a fifth peelably sealing wall (peelable seal 7) starting from an inner surface of a left edge (fig. 1a); and peelably sealing a sixth peelably sealing wall (peelable seal 6), wherein both the fifth peelably sealing wall and the sixth peelably sealing wall connect at a first connection port (point 9) to form the third peelably sealing wall (fig. 1aq, ¶ 0037), such configuration allowing for pressure from the liquid to be concentrated towards the connection point such that when one or more of the peelable seals are ruptured and thus opened the opening pressure will propagate along the respective peelable seal such that each peelable seal is fully opened (¶ 0015).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the third peelably sealing wall of Trouilly in view of Di Naro such that it comprises peelably sealing a fifth peelably sealing wall starting from an inner surface of the left edge; and peelably sealing a sixth peelably sealing wall starting from the first peelably sealing wall, wherein both the fifth peelably sealing wall and the sixth peelably sealing wall connect at a first connection point to form the third peelably sealing wall, as taught by Schroder, in order to allow for pressure from the liquid to be concentrated towards the connection point such that when one or more of the peelable seals are ruptured and thus opened the opening pressure will propagate along the respective peelable seal such that each peelable seal is fully opened (Schroder ¶ 0015).
Regarding claim 18, Trouilly in view of Di Naro fail to disclose wherein the peelably sealing the fourth peelably sealing wall comprises: peelably sealing an eighth peelably sealing wall starting from an inner surface of the right edge; and peelably sealing a ninth peelably sealing wall starting from the second peelably sealing wall, wherein both the eighth peelably sealing wall and the ninth peelably sealing wall connect at a second connection point to form the third peelably sealing wall.
Schroder teaches (fig. 1a) a method of manufacturing a system, the method comprising: producing a flexible multi-chamber bag (1) and thus in the same field of endeavor, wherein peelably sealing a fourth peelably sealing wall comprises: peelably sealing an eighth peelably sealing wall (peelable seal 6) starting from an inner surface of a right edge (fig. 1a); and peelably sealing a ninth peelably sealing wall (peelable seal 7), wherein both the eighth peelably sealing wall and the ninth peelably sealing wall connect at a second connection port (point 9) to form the fourth peelably sealing wall (fig. 1aq, ¶ 0037), such configuration allowing for pressure from the liquid to be concentrated towards the connection point such that when one or more of the peelable seals are ruptured and thus opened the opening pressure will propagate along the respective peelable seal such that each peelable seal is fully opened (¶ 0015).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fourth peelably sealing wall of Trouilly in view of Di Naro such that it comprises peelably sealing an eight peelably sealing wall starting from an inner surface of the right edge; and peelably sealing a ninth peelably sealing wall starting from the second peelably sealing wall, wherein both the eighth peelably sealing wall and the ninth peelably sealing wall connect at a second connection point to form the fourth peelably sealing wall, as taught by Schroder, in order to allow for pressure from the liquid to be concentrated towards the connection point such that when one or more of the peelable seals are ruptured and thus opened the opening pressure will propagate along the respective peelable seal such that each peelable seal is fully opened (Schroder ¶ 0015).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Carlsson et al. (Pub. No.: US 2014/0175126 A1) discloses a flexible multi-chamber bag. Brandl et al. (Pub. No.: US 2012/0310150 A1) discloses a flexible multi-chamber bag.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEAGAN NGO/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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