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 § 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 17-18 and 23 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 17 recites the limitation "the port tube" in ln. 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the port tube" in ln. 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites “wherein each of the first chamber, the second chamber, the third chamber, the fourth chamber and the fifth chamber comprise one port tube”. It is unclear whether the “one port tube” is the same or different as the first plurality of port tubes and the second plurality of port tubes recited in claim 1.
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, 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Di Naro (Pub. No.: US 2019/0142694 A1) and further in view of Pittet et al. (Pub. No.: US 2013/0046271 A1).
Regarding claim 1, Di Naro discloses (fig. 11) a flexible multi-chamber bag (100) for storing an reconstituting parenteral nutrition solutions (¶ 0026), the flexible multi-chamber bag comprising: two polymer films edge-sealed to form a first bag having a top edge, a bottom edge, a left edge and a right edge (¶ 0034);
A second plurality of tubes (port 112) with sidewalls non-peelably sealed between the two polymer films at the bottom edge to form a second plurality of port tubes (¶ 0007);
A first peelably sealing wall (seal 130) and a second peelably sealing wall (seal 170) between the two polymer films separating the first bag into a first chamber (110) between the first peelably sealing wall and the second peelably sealing wall, a first space between the left edge and the first peelably sealing wall (third chamber 160), a second space (second chamber 120) between the second peelably sealing wall and the right edge (¶ 0055).
Di Naro fails to disclose in the embodiment of fig. 11 the flexible multi-chamber bag comprising: a first plurality of tubes with sidewalls non-peelably sealed between the two polymer films at the top edge to form a first plurality of port tubes; a third peelably sealing wall extending from the left edge to the first peelably sealing wall to separate the first space to form a third chamber and a fourth chamber; and a fourth peelably sealing wall extending from the right edge to the second peelably sealing wall to separate the second space to form a second chamber and a fifth chamber.
However, Di Naro discloses (fig. 10) an embodiment comprising: a first tube with sidewalls non-peelably sealed between the two polymer films at the top edge to form a first port tube (port 122, fig. 10); and a peelably sealing wall (130, ¶ 0033-¶ 0034) and an additional peelably sealing wall (second breakable seal 170) extending from an edge to the peelably sealing wall to separate a space to form two chambers (110, 160) (fig. 10, ¶ 0054), in wherein the additional chambers are configured to hold another pharmaceutical product (¶ 0054) and wherein the first port tube is used for introducing solution into the chamber 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 multi-chamber bag of the embodiment of fig. 11 such that it comprises a first plurality of tubes with sidewalls non-peelably sealed between the two polymer films at the top edge to form a first plurality of port tubes; a third peelably sealing wall extending from the left edge to the first peelably sealing wall to separate the first space to form a third chamber and a fourth chamber; and a fourth peelably sealing wall extending from the right edge to the second peelably sealing wall to separate the second space to form a second chamber and a fifth chamber, as suggested by the embodiment of fig. 10 of Di Naro, in order to provide additional chambers are configured to hold another pharmaceutical product (¶ 0054) and the first port tubes configured to introduce solution into the chambers in a sterile manner (¶ 0032).
Di Naro fails to disclose wherein the flexible multi-chamber bag comprises a first portion near the top edge comprising the first plurality of port tubes, the first portion is non-peelably sealed and removed from the flexible multi-chamber bag.
Pittet teaches (fig. 1-3) a flexible multi-chamber bag (10, abstract) and thus in the same field of endeavor comprising: a first portion near an edge comprising a plurality of port tubes (filling tube 22, 23, 24) (fig. 1, ¶ 0012), and the first portion is non-peelably sealed and removed from the flexible multi-chamber bag (fig. 3, ¶ 0031- ¶ 0032), wherein the seal provides 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 multi-chamber bag of Di Naro such that it comprises a first portion near the top edge comprising the first plurality of port tubes, the first portion is non-peelably sealed and removed from the flexible multi-chamber bag, as taught by Pittet, in order to provide a liquid tight bag (Pittet, ¶ 0031).
Regarding claim 11, as discussed in claim 1 above, Di Naro embodiment of fig. 11 in view of the embodiment of fig. 10 disclose the first plurality of port tubes. The modified invention of Di Naro discloses wherein at least one of the first chamber, the second chamber and the third chamber connects to the first plurality of port tubes (Di Naro, fig. 10).
Regarding claim 12, Di Naro in view of Pittet fail to disclose wherein each of the first chamber, the second chamber and the third chamber connects to the first plurality of port tubes.
However, Di Naro discloses (fig. 10) each chamber including a port tube (fig. 10), such port tubes allowing for introduction of solution or product in a sterile manner (¶ 0031-¶ 0032).
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 each of the first chamber, the second chamber and the third chamber of Di Naro in view of Pittet such that they each connect to the first plurality of port tubes in order to allow for introduction of solution or product in a sterile manner (Di Naro ¶ 0031-¶ 0032).
Regarding claim 13, as discussed above in claim 1, Di Naro embodiment of fig. 11 in view of the embodiment of fig. 10 disclose the fourth and fifth chamber. The modified invention of Di Naro discloses wherein at least one of the fourth chamber and the fifth chamber connects to the second plurality of port tubes (Di Naro, fig. 11, port tubes 112).
Regarding claim 14, as discussed above in claim 1, Di Naro embodiment of fig. 11 in view of the embodiment of fig. 10 disclose the fourth and fifth chamber. The modified invention of Di Naro discloses wherein each of the fourth chamber and the fifth chamber connects to the second plurality of port tubes (Di Naro, fig. 11, port tubes 112).
Regarding claim 15, Di Naro discloses wherein the first chamber connects to an administration port and/or a medication port at the bottom edge (port 112, ¶ 0031).
Regarding claim 16, Di Naro in view of Pittet fail to disclose wherein the first chamber connects to both an administration port and a medication port at the bottom edge.
However, Di Naro discloses a chamber (second chamber 120) that connects to both an administration port (124) and a medication port (112) at the bottom edge (¶ 0031-¶ 0032), wherein the administration port and the medication port are configured to be used by a health care worker to administer product to a patient (¶ 0032) and introducing product into the chamber in a sterile manner (¶ 0031), respectively.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify first chamber of Di Naro in view of Pittet such that it connects to both an administration port and a medication port at the bottom edge, in order to provide an administration port configured to be used by a health care worker to administer product to a patient (¶ 0032) and a medication port for introducing product into the chamber in a sterile manner (¶ 0031).
Regarding claim 17, Di Naro in view of Pittet fail to disclose wherein the flexible multi-chamber bag comprises a second portion at the left corner of the flexible multi-chamber bag, the second portion comprises the port tube to the fourth chamber, and the second portion is non-peelably sealed and removed from the flexible multi-chamber bag.
However, as discussed in claim 1 above, Pittet discloses a portion comprising a plurality of port tubes (filling tube 22, 23, 24) (fig. 1, ¶ 0012), and the portion is non-peelably sealed and removed from the flexible multi-chamber bag (fig. 3, ¶ 0031- ¶ 0032), wherein the seal provides a liquid tight bag (¶ 0031).
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 multi-chamber bag of Di Naro in view of Pittet such that it comprises a second portion at the left corner of the flexible multi-chamber bag, the second portion comprises the port tube to the fourth chamber, and the second portion is non-peelably sealed and removed from the flexible multi-chamber bag, as suggested by Pittet, in order to provide a liquid tight bag (Pittet, ¶ 0031).
Regarding claim 18, Di Naro in view of Pittet fail to disclose wherein the flexible multi-chamber bag comprises a third portion at the right corner of the flexible multi-chamber bag, the second portion comprises the port tube to the fifth chamber, and the third portion is non-peelably sealed and removed from the flexible multi-chamber bag.
However, as discussed in claim 1 above, Pittet discloses a portion comprising a plurality of port tubes (filling tube 22, 23, 24) (fig. 1, ¶ 0012), and the portion is non-peelably sealed and removed from the flexible multi-chamber bag (fig. 3, ¶ 0031- ¶ 0032), wherein the seal provides a liquid tight bag (¶ 0031).
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 multi-chamber bag of Di Naro in view of Pittet such that it comprises a third portion at the right corner of the flexible multi-chamber bag, the third portion comprises the port tube to the fifth chamber, and the third portion is non-peelably sealed and removed from the flexible multi-chamber bag, as suggested by Pittet, in order to provide a liquid tight bag (Pittet, ¶ 0031).
Claim(s) 2-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Di Naro in view of Pittet, as applied to claim 1 above, and further in view of Schroder (Pub. No.: US 2010/0318058 A1).
Regarding claim 2, Di Naro in view of Pittet fail to disclose wherein the third peelably sealing wall comprises a fifth peelably sealing wall starting from an inner surface from an inner surface of the left edge and a sixth peelably sealing wall starting from the first peelably sealing wall, and 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 flexible multi-chamber bag (container 1, abstract) and thus in the same field of endeavor, wherein a third peelably sealing wall comprises a fifth peelably sealing wall (second peelable seal 7) starting from an inner surface of a left edge (fig. 1a, ¶ 0043) and a sixth peelably sealing wall (first peelable seal 6), and 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 (point 9, fig. 1a, ¶ 0037), wherein such configuration allows for pressure from the liquid to be concentrated toward 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 Di Naro in view of Pittet such that it comprises the fifth peelably sealing wall starting from an inner surface from an inner surface of the left edge and a sixth peelably sealing wall starting from the first peelably sealing wall, and 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, such that the sixth peelably sealing wall starts from the first peelably sealing wall, as such configuration allows for pressure from the liquid to be concentrated toward 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 3, as discussed above in claim 2, Di Naro in view of Pittet and further in view of Schroder disclose the fifth and sixth peelably sealing wall. Di Naro in view of Pittet and further in view of Schroder further disclose wherein the left edge and the fifth peelably sealing wall have an angle of 100 degrees toward the top edge direction (Schroder fig. 1a, angle alpha is 10 degrees thus left edge and fifth peelably sealing wall will be 100 degrees, ¶ 0038), which falls within the claimed range of greater than 90 degrees, and the fifth peelably sealing wall and the sixth peelably sealing wall around the first connection point have an angle of 130 degrees (Schroder beta, ¶ 0038, fig. 1), which falls within the claimed range of between 130 and 170 degrees.
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Regarding claim 4, as discussed above in claims 2 and 3, Di Naro in view of Pittet and further in view of Schroder disclose the fifth and sixth peelably sealing wall. Di Naro in view of Pittet and further in view of Schroder further disclose wherein the left edge and the fifth peelably sealing wall have an angle of 100 degrees toward the top edge direction (Schroder fig. 1a, angle alpha is 10 degrees thus left edge and fifth peelably sealing wall will be 100 degrees, ¶ 0038).
Di Naro in view of Pittet and further in view of Schroder fail to disclose the fifth peelably sealing wall and the sixth peelably sealing wall around the first connection point have an angle in the range of between 150 and 160 degrees.
However, Schroder teaches (fig. 1a) a peelably sealing wall (third peelable seal 8) having a connection point with the sixth peelably sealing wall (first peelable seal 6), wherein the peelably sealing wall and the sixth peelably sealing wall around the connection point have an angle in the range of 30 to 180 degrees (the angle beta can range from 20 to 130 degrees and the angle gamma can range from 160 to 200 degrees, thus the angle between the wall 8 and wall 6 can range from 30 to 180 degrees, ¶ 0012), which overlaps with the claimed range of 150 to 160 degrees, wherein such angles allow for pressure from the liquid to be concentrated toward 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). 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 fifth and sixth peelably sealing wall around the first connection point of Di Naro in view of Pittet and further in view of Schroder such that they have an angle in the range of between 150 and 160 degrees, as taught by Schroder, as such angles allow for pressure from the liquid to be concentrated toward 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).
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Regarding claim 5, as discussed above in claims 2 and 3, Di Naro in view of Pittet and further in view of Schroder disclose the fifth and sixth peelably sealing wall. Di Naro in view of Pittet and further in view of Schroder fail to disclose wherein the left edge and the fifth peelably sealing wall have the angel of 102 degrees toward the top edge direction, and the fifth peelably sealing wall and the sixth peelably sealing wall around the first connection point have an angle in the range of 156 degrees.
However, Schroder teaches that the left edge and the fifth peelably sealing wall have an angle of between 100 and 170 degrees from the top edge direction (angle alpha is between 10 and 80 degrees, ¶ 0012) which encompasses the claimed value of 102 degrees. Schroder further teaches a peelably sealing wall (third peelable seal 8) having a connection point with the sixth peelably sealing wall (first peelable seal 6), wherein the peelably sealing wall and the sixth peelably sealing wall around the connection point have an angle in the range of 30 to 180 degrees (the angle beta can range from 20 to 130 degrees and the angle gamma can range from 160 to 200 degrees, thus the angle between the wall 8 and wall 6 can range from 30 to 180 degrees, ¶ 0012), which encompasses the claimed value of 156 degrees, wherein such angles allow for pressure from the liquid to be concentrated toward 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). 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 fifth and sixth peelably sealing wall of Di Naro in view of Pittet and further in view of Schroder the left edge and the fifth peelably sealing wall have the angel of 102 degrees toward the top edge direction, and the fifth peelably sealing wall and the sixth peelably sealing wall around the first connection point have an angle in the range of 156 degrees, as taught by Schroder, as such angles allow for pressure from the liquid to be concentrated toward 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 6, Di Naro in view of Pittet fail to disclose wherein a seventh peelably sealing wall starts from a first connection point and extends to the bottom edge to separate the fourth chamber to form a sixth chamber between the seventh peelably sealing wall and the first peelably sealing wall.
Schroder teaches (fig. 1a) a flexible multi-chamber bag (container 1, abstract) and thus in the same field of endeavor, comprising: a seventh peelably sealing wall (second peelable seal 8) starting from a first connection point (point 9) and extends to a bottom edge (see curved weld 16) to separate a fourth chamber (third compartment 4) to form a sixth chamber (second compartment 3) (fig. 1a), wherein the seventh peelably sealing wall allows for an additional chamber (¶ 0001).
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 multi-chamber bag of Di Naro in view of Pittet such that it includes a seventh peelably sealing wall starts from a first connection point and extends to the bottom edge to separate the fourth chamber to form a sixth chamber between the seventh peelably sealing wall and the first peelably sealing wall, as taught by Schroder, in order to allow for an additional chamber (Schroder ¶ 0001).
Regarding claim 7, Di Naro in view of Pittet fail to disclose wherein the fourth peelably sealing wall comprises an eighth peelably sealing wall starting from an inner surface from an inner surface of the right edge and a ninth peelably sealing wall starting from the second peelably sealing wall, and 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.
Schroder teaches (fig. 1a) a flexible multi-chamber bag (container 1, abstract) and thus in the same field of endeavor, wherein a fourth peelably sealing wall comprises an eighth peelably sealing wall (second peelable seal 7) and a ninth peelably sealing wall (first peelable seal 6), and 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 (point 9, fig. 1a, ¶ 0037), wherein such configuration allows for pressure from the liquid to be concentrated toward 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 Di Naro in view of Pittet such that it comprises the eighth peelably sealing wall and a ninth peelably sealing wall starting from the first peelably sealing wall, and 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, such that the eighth peelably sealing wall starts from the inner surface of the right edge and the ninth peelably sealing wall starts from the second peelably sealing wall, as such configuration allows for pressure from the liquid to be concentrated toward 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 8, as discussed above in claim 8, Di Naro in view of Pittet and further in view of Schroder disclose the eighth ninth sixth peelably sealing wall. Di Naro in view of Pittet and further in view of Schroder further disclose wherein eighth peelably sealing wall has an angle of 100 degrees toward the top edge direction (fig. 1a, angle alpha is 10 degrees thus left edge and fifth peelably sealing wall will be 100 degrees, ¶ 0038), which falls within the claimed range of greater than 90 degrees, and the eighth peelably sealing wall and the ninth peelably sealing wall around the second connection point have an angle of 130 degrees (beta, ¶ 0038, fig. 1), which falls within the claimed range of between 130 and 170 degrees.
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Regarding claim 9, as discussed above in claims 7 and 8, Di Naro in view of Pittet and further in view of Schroder disclose the eighth and ninth peelably sealing wall. Di Naro in view of Pittet and further in view of Schroder further disclose wherein eighth peelably sealing wall has an angle of 100 degrees toward the top edge direction (Schroder fig. 1a, angle alpha is 10 degrees thus left edge and fifth peelably sealing wall will be 100 degrees, ¶ 0038).
Di Naro in view of Pittet and further in view of Schroder fail to disclose the eighth peelably sealing wall and the ninth peelably sealing wall around the second connection point have an angle in the range of between 150 and 160 degrees.
However, Schroder teaches (fig. 1a) a peelably sealing wall (third peelable seal 8) having a connection point with the ninth peelably sealing wall (first peelable seal 6), wherein the peelably sealing wall and the sixth peelably sealing wall around the connection point have an angle in the range of 30 to 180 degrees (the angle beta can range from 20 to 130 degrees and the angle gamma can range from 160 to 200 degrees, thus the angle between the wall 8 and wall 6 can range from 30 to 180 degrees, ¶ 0012), which overlaps with the claimed range of 150 to 160 degrees, wherein such angles allow for pressure from the liquid to be concentrated toward 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). 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 eighth and ninth peelably sealing wall around the second connection point of Di Naro in view of Pittet and further in view of Schroder such that they have an angle in the range of between 150 and 160 degrees, as taught by Schroder, as such angles allow for pressure from the liquid to be concentrated toward 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).
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Regarding claim 10, as discussed above in claims 7-9, Di Naro in view of Pittet and further in view of Schroder disclose the eighth and ninth peelably sealing wall, wherein the eighth peelably sealing wall and ninth peelably sealing wall around the second connection point have an angle of between 30 to 180 degrees (the angle beta can range from 20 to 130 degrees and the angle gamma can range from 160 to 200 degrees, thus the angle between the wall 8 and wall 6 can range from 30 to 180 degrees, ¶ 0012), which encompasses the claimed value of 156 degrees.
Di Naro in view of Pittet and further in view of Schroder fail to disclose wherein the right edge and the eighth peelably sealing wall have the angle of 102 degrees toward the top edge direction.
However, Schroder teaches that the left edge and the fifth peelably sealing wall have an angle of between 100 and 170 degrees from the top edge direction (angle alpha is between 10 and 80 degrees, ¶ 0012) which encompasses the claimed value of 102 degrees, wherein such angles allow for pressure from the liquid to be concentrated toward 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). 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 eighth peelably sealing wall of Di Naro in view of Pittet and further in view of Schroder it has an angle of 102 degrees toward the top edge direction, as taught by Schroder, as such angles allow for pressure from the liquid to be concentrated toward 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).
Claim(s) 19-21, 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Di Naro in view of Pittet, as applied to claim 1 above, and further in view of Trouilly et al. (Pub. No.: US 2007/0031976 A1).
Regarding claim 19, as discussed above in claim 1, Di Naro in view of Pittet disclose the flexible multi-chamber bag of claim 1. Di Naro in view of Pittet fail to disclose an “all-in-one” parenteral nutrition system comprising parenteral nutrition solutions in the flexible multi-chamber bag, the “all-in-one” parenteral nutrition system comprising: the first chamber comprising an amino acids solution; the second chamber comprising a glucose solution; the third chamber comprising a lipid emulsion; the fourth chamber comprising a vitamins solution or emulsion; and the fifth chamber comprising a trace elements solution.
Trouilly teaches (fig. 1) an “all-in-one” parenteral nutrition system comprising parenteral nutrition solutions in the flexible multi-chamber bag (container 10) (¶ 0002), the “all-in-one” parenteral nutrition system comprising: an amino acids solution; a glucose solution; a lipid emulsion; a vitamins solution or emulsion; and a trace elements solution (¶ 0008), wherein such elements are generally components of a parenteral nutritional solution (¶ 0008).
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 flexible multi-chamber bag of Di Naro in view of Pittet such that it is an “all-in-one’ parenteral nutrition system comprising: the first chamber comprising an amino acids solution; the second chamber comprising a glucose solution; the third chamber comprising a lipid emulsion; the fourth chamber comprising a vitamins solution or emulsion; and the fifth chamber comprising a trace elements solution, as taught by Trouilly, as such elements are generally components of a parenteral nutritional solution (Trouilly ¶ 0008).
Regarding claim 20, as discussed in claim 19 above, Di Naro in view of Pittet and further in view of Trouilly disclose the first chamber comprising an amino acids solution. Di Naro in view of Pittet and further in view of Trouilly further disclose wherein the first chamber comprises vitamins or trace elements (Trouilly, electrolytes are included in the amino acid component, ¶ 0099, electrolytes are considered to be trace elements, ¶ 0008-¶ 0009).
Regarding claim 20, as discussed in claim 19 above, Di Naro in view of Pittet and further in view of Trouilly disclose the second chamber comprising a glucose solution. Di Naro in view of Pittet and further in view of Trouilly further disclose wherein the second chamber comprises vitamins or trace elements (Trouilly, electrolytes are included in the carbohydrate component, ¶ 0099, electrolytes are considered to be trace elements, ¶ 0008-¶ 0009).
Regarding claim 23, as discussed above in claim 1, Di Naro embodiment of fig. 11 in view of the embodiment of fig. 10 disclose the fourth and fifth chamber. The modified invention of Di Naro discloses wherein each of the first chamber, the fourth chamber and the fifth chamber comprise one port tube (port tubes 112) for addition of contents into the chambers (Di Naro, fig. 11, ¶ 0031).
Further, as discussed in claim 1 above, Di Naro embodiment of fig. 11 in view of the embodiment of fig. 10 disclose the first plurality of port tubes. The modified invention of Di Naro discloses wherein each of the second chamber and the third chamber comprise one port tube (see port 122) (fig. 10, ¶ 0032).
Regarding claim 24, as discussed in claim 1 and 23 above, Di Naro embodiment of fig. 11 in view of the embodiment of fig. 10 disclose the disclose the third chamber, fourth chamber and fifth chamber having port tubes. Di Naro further discloses wherein the port tube for each of the third chamber, the fourth chamber and the fifth chamber is sealed or closed after the addition of the contents into the chambers (¶ 0040).
Regarding claim 25, Di Naro in view of Pittet and further in view of Trouilly fail to disclose wherein port-tube-containing portions for the fourth chamber and the fifth chamber are non-peelably sealed and removed from the rest of the flexible multi-chamber bag.
However, as discussed in claim 1 above, Pittet discloses a portion comprising a plurality of port tubes (filling tube 22, 23, 24) (fig. 1, ¶ 0012), and the portion is non-peelably sealed and removed from the flexible multi-chamber bag (fig. 3, ¶ 0031- ¶ 0032), wherein the seal provides a liquid tight bag (¶ 0031).
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 multi-chamber bag of Di Naro in view of Pittet such that the port-tube-containing portions for the fourth chamber and the fifth chamber are non-peelably sealed and removed from the rest of the flexible multi-chamber bag, as suggested by Pittet, in order to provide a liquid tight bag (Pittet, ¶ 0031).
Regarding claim 26, as discussed above in claim 1, Di Naro in view of Pittet disclose the first portion near the top edge comprising the first plurality of port tubes. Accordingly, Di Naro in view of Pittet disclose wherein the first portion comprises at least one port tube at the top edge for the first chamber, the second chamber and/or the third chamber.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naro in view of Pittet and further in view of Trouilly, as applied to claim 19 above, and further in view of Yoshikawa et al. (Pub. No.: US 2007/0299391 A1).
Regarding claim 22, Naro in view of Pittet and further in view of Trouilly fail to disclose wherein the third chamber further comprises fat-soluble vitamins.
Yoshikawa teaches (fig. 1) a parenteral nutrition system (¶ 0068) and thus in the same field of endeavor comprising a chamber comprising fat-soluble vitamins (¶ 0024) wherein such component is suitable for a parenteral nutrition system (¶ 0068).
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 chamber of Naro in view of Pittet and further in view of Trouilly such that it comprises fat-soluble vitamins, as taught by Yoshikawa, as such component is suitable for a parenteral nutrition system (Yoshikawa ¶ 0068).
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. Pittet et al. (Pub. No.: US 2013/0039606 A1) discloses a flexible multi-chamber bag.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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