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 .
Response to Amendment
The Amendment filed on 5/1/2026 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection previously set forth in the non-final Office Action mailed 2/2/2026.
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) 1-4 and 7-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2016/0194589, hereinafter Linderfelt.
Regarding claim 1, Linderfelt teaches a bioprocessing apparatus (figure 1), comprising: a flexible bag (item 1) having an outer boundary that defines an interior volume configured to contain a fluid (paragraph [0021]); and an integral fluid conduit (item 3) within the flexible bag (figure 1), comprising: a panel of material (item 4) joined to an interior sidewall of the flexible bag (paragraph [0014]) so as to define a channel (item 3) between the interior sidewall of the flexible bag and the panel of material (paragraph [0014]), wherein the integral fluid conduit includes a first terminal end (the left side of item 3) and a second terminal end (the right side of item 3), each being located within the outer boundary of the flexible bag (figure 1), wherein the first terminal end (the right side of item 3) is fluidly connected to a first port on top of the flexible bag (the opening in the top of item 5), and wherein the second terminal end (the left side of item 3) is fluidly connected to a second port (the opening in the top of item 6) or a first bottom outlet opening that is in fluid communication with the interior volume (the lowest pore in the dialysis membrane).
Regarding claim 2, Linderfelt teaches the integral fluid conduit includes the first bottom outlet opening (the lowest pore in the dialysis membrane), the first bottom outlet opening being in fluid communication with the interior volume (paragraph [0021]).
Regarding claim 3, Linderfelt teaches wherein the first port (item 5) on top of the flexible bag (figure 1), wherein the first terminal end is fluidly connected to the first port on top of the flexible bag (figure 1).
Regarding claim 4, Linderfelt teaches the second port (item 5) at a bottom of the flexible bag (figure 1, the bottom of the bag is considered to be the right side of the bag in figure 1); wherein the second terminal end of the integral fluid conduit is fluidly connected to the second port (figure 1), and wherein the channel of the 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 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 integral fluid conduit 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.
Regarding claim 10, Linderfelt teaches further comprising at least one tube (items 5 and 6), wherein a length of the at least one tube is at least partially disposed within the channel of the integral fluid conduit (figure 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Linderfelt in view of CA 2642174, hereinafter Hill.
Regarding claim 5, Linderfelt teaches wherein the second terminal end is fluidly connected to the first bottom outlet opening (the lowest pore in the dialysis membrane) that is in fluid communication with the interior volume (paragraph [0021]), and wherein the panel of material is an elongated piece of material fixed to the interior sidewall of the flexible bag so as to create opposed vertically extending seals with the interior sidewall (figure 1), such that the channel is formed between the elongated piece of material and the interior sidewall (figure 1).
Linderfelt is silent as to how the elongated piece of material is fixed to the inner sidewall of the flexible bag.
Hill teaches to use adhesive or plastic welding to fix an elongated piece of material to the interior sidewall of a flexible bag (Hill, pages 9-10, lines 22-2).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., heat sealing or gluing the elongated piece of material), and that in combination, each element merely would have performed the same function as it did separately (i.e., fixing the elongated piece of material), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to combine the elongated piece of material of reference Linderfelt with heat sealing or gluing the elongated piece of material of reference Hill, since the result would have been predictable.
Allowable Subject Matter
Claim 6 is 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: Linderfelt nor Hill teaches at least one of the opposed vertically extending seals is shorter than a length of the elongated piece of material, creating at least one flap at the first bottom outlet that opens in fluid communication with the interior volume, and wherein the at least one flap promotes turbulent flow when an introduced fluid flows in a substantially gravitational direction out of the first bottom outlet into the interior volume to aid in mixing when the interior volume contains the fluid.
Response to Arguments
Applicant's arguments filed 5/1/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument that Linderfelt does not teach “a first bottom opening that is in fluid communication with the interior volume is not found persuasive. Firstly, the claim recites that “the second terminal end is fluidly connected to a second port or a first bottom outlet opening that is in fluid communication with the interior volume” and therefore the prior art would anticipate the claim if the second terminal end is fluidly connected to the second port or the second terminal end is a first bottom outlet opening that is in fluid communication with the interior volume. The applicant is seeming to state that since the prior art does not teach the second terminal end is a first bottom outlet opening that is in fluid communication with the interior volume that Linderfelt would fail to teach the claim. However, as shown above, Linderfelt teaches if the second terminal end is fluidly connected to the second port. Additionally, Linderfelt can also be interpreted such that it also reads on the second terminal end is a first bottom outlet opening that is in fluid communication with the interior volume as the dialysis membrane which forms the integral fluid conduit has pores and the pores are considered to be openings and the lowest pore in the dialysis membrane is therefore considered to read on the first bottom outlet thereby anticipating the claim.
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 MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 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, Maris Kessel can be reached at (571)270-7698. 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.
/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
Prosecution Insights