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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 12/29/2025 is acknowledged. The traversal is on the ground(s) that WO 2019/199406 does not teach a panel of material which define a fluid channel between the interior sidewall and the panel of material and therefore this limitation is a special technical feature. This is not found persuasive because the claim only states that is fluid channel is formed and item 18 is able to operate as a fluid channel and thereby read on the instant claims. The fact that the reference discloses another use for item 18, doesn’t prevent the ability for item 18 to operate as a fluid channel. Additionally, Hill teaches all of the limitations of claim 1 (see the rejection below) and therefore also shows that the specified limitation is not a special technical feature
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 4 and 9 are objected to because of the following informalities:
Claim 4, line 3 recites “second port,” however, as claim 4 depends upon claim 1 there isn’t a first port.
Claim 9, line 2 recites “conduct” and should recite “conduit.”
Appropriate correction is required.
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 4 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites that the “integral fluid conduit is not in fluid communication with the interior volume.” However, the integral fluid conduit is the entire panel of material, both the inside and outside of the panel of material. Therefore, the integral fluid conduit would have to be in fluid communication with the interior volume as the integral fluid conduit separates the interior volume and the inside of the integral fluid conduit. For examination purposes, it is interpreted that the fluid channel is not in fluid communication with the interior volume.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 7 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CA 2642174, hereinafter Hill.
Regarding claim 1, Hill teaches a bioprocessing apparatus (abstract) for the manufacture of biopharmaceutical products (intended use MPEP § 2114 (II)), comprising: a flexible bag (item 5) having an interior volume (the interior of item 5) configured to contain a fluid (intended use MPEP § 2114 (II) and is taught on page 7, lines 21-23); and an integral fluid conduit (item 9c) within the flexible bioprocessing bag (figure 4), comprising: a panel of material joined to an interior sidewall of the flexible bag so as to define a fluid channel between the interior sidewall of the flexible bag and the panel of material (pages 9-10, lines 22-2).
Regarding claim 2, Hill teaches wherein: the integral fluid conduit includes a bottom outlet opening, the bottom outlet opening in fluid communication with the interior volume (page 8, lines 15-16).
Regarding claim 5, Hill teaches wherein the panel of material is an elongated piece of material and is welded, heat sealed, or glued to the interior sidewall of the flexible bag to create opposed vertically extending seals with the interior sidewall (pages 9-10, lines 22-2), such that a channel is formed between the elongated piece of material and the interior sidewall (pages 9-10, lines 22-2 and figure 4).
Regarding claim 7, Hill teaches wherein the panel of material includes pores and /or comprises a porous membrane (page 8, lines 18-22).
Regarding claim 9, Hill teaches wherein the fluid conduit is configured to act as a sparger, a filter, a sterile addition tube, a tube holder, a baffle, or a temperature regulating conduit (page 8, lines 15-22).
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.
Claim(s) 1, 3-5 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2016/0194589, hereinafter Linderfelt in view of Hill.
Regarding claim 1, Linderfelt teaches a bioprocessing apparatus (figure 2) for the manufacture of biopharmaceutical products (intended use MPEP § 2114 (II)), comprising: a flexible bag (item 11) having an interior volume configured to contain a fluid (paragraph [0021]); and an integral fluid conduit (item 13) within the flexible bioprocessing bag (figure 2).
Linderfelt fails to teach the integral fluid conduit comprises a panel of material joined to an interior sidewall of the flexible bag so as to define a fluid channel between the interior sidewall of the flexible bag and the panel of material.
Hill teaches a flexible bag (Hill, item 5) which has a fluid conduit (Hill, item 9c) within the bag which comprises a panel of material joined to an interior sidewall of the flexible bag so as to define a fluid channel between the interior sidewall of the flexible bag and the panel of material (Hill, pages 9-10, lines 22-2) so that the conduit is integrated into the wall of the bag and is accessible as the bag is moved from a collapsed position to a filled position and is conveniently made by fixing edges of a strip of material on the inner surface of the bag (Hill, pages 9-10, lines 22-2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the fluid conduit of Linderfelt as a panel of material joined to an interior sidewall of the flexible bag so as to define a fluid channel between the interior sidewall of the flexible bag and the panel of material because it would allow for the conduit to be integrated into the wall of the bag and is accessible as the bag is moved from a collapsed position to a filled position and is conveniently made by fixing edges of a strip of material on the inner surface of the bag (Hill, pages 9-10, lines 22-2).
Regarding claim 3, Linderfelt teaches a first port (item 15) in a top of the flexible bag (figure 2); wherein a top of the integral fluid conduit is fluidly connected to the first port (figure 2).
Regarding claim 4, Linderfelt teaches a second port (item 16) in a bottom of the flexible bag (figure 2); wherein a bottom of the integral fluid conduit is fluidly connected to the second port (figure 2); and wherein integral fluid conduit is not in fluid communication with the interior volume (neither end of the fluid conduit is in fluid communication with the interior volume of the bag and as described in paragraph [00022] of the instant specification, not being in fluid communication means that both ends of the conduit is attached to a first and second port).
Regarding claim 5, modified Linderfelt teaches wherein the panel of material is an elongated piece of material and is welded, heat sealed, or glued to the interior sidewall of the flexible bag to create opposed vertically extending seals with the interior sidewall (Hill, pages 9-10, lines 22-2), such that a channel is formed between the elongated piece of material and the interior sidewall (Hill, pages 9-10, lines 22-2).
Regarding claim 7, Linderfelt teaches wherein the panel of material includes pores and /or comprises a porous membrane (paragraph [0024]).
Regarding claim 8, Linderfelt teaches wherein the panel of material is at least partially made from or coated with a foam-reducing material (paragraph [0024], the membranes would reduce foam compared to a large pored material).
Regarding claim 9, Linderfelt teaches wherein the fluid conduct is configured to act as a sparger, a filter (paragraph [0024]), a sterile addition tube (paragraph [0024]), a tube holder, a baffle, or a temperature regulating conduit.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Linderfelt and Hill as applied to claim 5 above, and further in view of United States Patent No. 5,403,741, hereinafter Holbrook.
Regarding claim 6, Linderfelt and Hill teach all limitations of claim 5; however, they fail to teach wherein one or both of the opposed vertically extending seals is shorter than a length of the elongated piece of material, creating a flap.
Holbrook teaches a device for microorganism culture which ahs a flap which covers the aperture of a conduit (Holbrook, column 12, lines 50-52).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made one or both of the opposed vertically extending seals is shorter than a length of the elongated piece of material, creating a flap because it would cover the opening of the conduit (Holbrook, column 12, lines 50-52).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Linderfelt and Hill as applied to claim 1 above, and further in view of United States Application Publication No. 2012/0284991, hereinafter Kusz.
Regarding claim 10, Linderfelt and Hill teach all limitations of claim 1; however, they fail to teach at least one tube, the at least one tube being at least partially located within the integral fluid conduit.
Kusz teaches a configurable port in which an adapter is inserted into the tubular port to form a snap-fit engagement with the connector such that movement opposite a direction of insertion is prevented (Kusz, paragraph [0014]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added an adapter (at least one tube) inserted into the tubular port (the integral fluid conduit) to form a snap-fit engagement with the connector such that movement opposite a direction of insertion is prevented (Kusz, paragraph [0014]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796