Prosecution Insights
Last updated: April 18, 2026
Application No. 18/038,888

CULTURE VESSEL FOR A BIOPROCESSING SYSTEM

Non-Final OA §103§112
Filed
May 25, 2023
Examiner
FISHER, BRITTANY I
Art Unit
1796
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Kite Pharma Inc.
OA Round
1 (Non-Final)
84%
Grant Probability
Favorable
1-2
OA Rounds
2y 11m
To Grant
96%
With Interview

Examiner Intelligence

Grants 84% — above average
84%
Career Allow Rate
438 granted / 520 resolved
+19.2% vs TC avg
Moderate +12% lift
Without
With
+12.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
26 currently pending
Career history
546
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
41.7%
+1.7% vs TC avg
§102
31.9%
-8.1% vs TC avg
§112
20.6%
-19.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 520 resolved cases

Office Action

§103 §112
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. Drawings The drawings were received on 5/25/2023. These drawings are acceptable. Election/Restrictions Applicant’s election with traverse of Group I, claim 1-15, in the reply filed on February 10, 2026 is acknowledged. Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 10, 2026. Applicant's election with traverse of Group I, claims 1-14, in the reply filed on February 10, 2026 is acknowledged. The traversal is on the ground(s) that heat stakes are special technical features. This is not found persuasive because the instant application is a national stage entry filed under 35 U.S.C. 371 and is subject to lack of unity practice, see MPEP 1893.03(d). It is noted that inventions listed as Groups I and II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features as set forth on pages 4-5 of the previous Office Action , specifically that the special technical feature is a bioreactor vessel described in both independent claims 1 and 16, but wherein the recited heat stakes of the bioreactor vessel of claim 1 are not recited in the disposable kit of claim 16 . The requirement is still deemed proper and is therefore made FINAL. Claim Objections Claim 11 is objected to because of the following informalities: The word “support” appears to be erroneously added before the term “corresponding” in line 2. 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 appl icant regards as his invention. Claim 5 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 5 recites the limitation "the plurality of tubing connections" in line 2. There is insufficient antecedent basis for this limitation in the claim. 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. 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 is/are r ejected under 35 U.S.C. 103 as being unpatentable over Ingber et al (US 2015/0209783 A1) . With respect to claim 1 Ingber discloses a bioreactor vessel (bubble trap 120 , Para. 0045 ) comprising: A base (first body portion 312, See Fig. 3A) having a plurality of through openings ( inlet and outlet ports 342 and 344, See Fig. 3B) (See Para. 0046 ) ; A lid (second body portion 316, See Fig. 3A) connected to the base via a plurality of threaded fasteners or a clamping mechanism (See Para. 0047); and A gas-permeable, liquid impermeable membrane (membrane 320, See Fig. 3A and Para. 0046; See Paras. 0041 and 0050 for discussion of how the membrane is gas permeable but liquid impermeable; also see Para. 0009) sandwiched between the base and the lid and held in position by the plurality of fasteners (See Para. 0047). The embodiment depicted in Fig. 3 of Ingber fails to disclose the use of heat stakes to hold the lid to the base and position the sandwiched membrane. Fig. 2 and Para. 0038 of Ingber teach an alternative embodiment of the bubble trap 120, wherein the assembly of layers and body portions, can be held together by thread forming screws, nuts and bolts, clips, clamps, pins as well as or in addition to the use of heat staking, glue (e.g., biocompatible, low absorption adhesives), welding and various forms of bonding (e.g. thermal, solvent-activated, UV activated, ultrasonic) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of heat staking, as taught by Fig. 2 of Ingber, as a choice of fastening the plurality of layers together depicted in Fig. 3 of Ingber, such that various layers of device may be permanently bonded together in certain desired applications (See Para. 0038 of Ingber). With respect to claim 2, Ingber discloses that the lid is devoid of sharp corners (See Figs. 3B/4B and Para. 0063 for discussion of how the bubble trap can be formed from a tubular structure). With respect to claim 3, although there is no specific teaching that the corners of the lid have a specific shape and/or differing shapes, the courts held In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) that a change in shape is matter of choice in which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed apparatus was significant. Thus, it would have been obvious to one of ordinary skill in the art at the time of filing to configure the corners of the lid to have any specific shape that is appropriate to the desired application and fabrication method of the bubble trap . Applicant should also note that Figs. 3B/4B depict the bubb le trap as having a cylindrical configuration, which would imply a round shape of the device. With respect to claim 4 Ingber depicts a plurality of tubing connections (inlet port 342 and outlet port 344, See Fig, 3B and Para. 0046) configured to provide for vertical entry or exit of fluid to and from the bioreactor vessel . Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Ingber and the apparatus of Itoh is capable of the recitation of claim 4 . As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Itoh (see MPEP §2114). Furthermore, it should be noted that the inlet and outlet ports would be capable of connecting with tubing to enable vertical entry or exit of an applied fluid. Claim(s) 1, 4, 5, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coppeta et al (US 2018/0142196 A1) in view of Ingber et al (US 2015/0209783 A1) . With respect to claim 1, Coppeta discloses a bioreactor vessel (bi-layer multi-well cell culture platform 105, See Fig. 8) , comprising: A base (embossed plastic material 720b, See Fig. 8 and Para. 0088) for having a plurality of through openings ( microchannel structures 125b ) ; A lid (first structural layer 550, See Fig. 8) connected to the base via adhesive films (See Para. 0090) ; and A gas-permeable, liquid impermeable membrane (membrane 140, See Para. 088 for discussion of how the membrane is made of gas/oxygen permeable polymers such as fluorinated ethylene propylene (FEP)) sandwiched between the base and the lid and held in position by the adhesives (See Para. 0090). Coppeta fails to disclose that the lid is connected to the base via a plurality of heat stakes and that the membrane is held in position between the lid and base by the plurality of heat stakes. Ingber teaches a bubble trap 120, wherein an assembly of layers and body portions, can be held together by thread forming screws, nuts and bolts, clips, clamps, pins as well as or in addition to the use of heat staking, glue (e.g., biocompatible, low absorption adhesives), welding and various forms of bonding (e.g. thermal, solvent-activated, UV activated, ultrasonic) (See Fig. 2 and Para. 0038). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of heat staking, as taught by Fig. 2 of Ingber, as a choice of fastening the plurality of layers together of the cell culture system of Coppeta, such that various layers of device may be permanently bonded together, which may desirable in certain desired applications (See Para. 0038 of Ingber). With respect to claim 4 the combination of Coppeta and Ingber teaches a plurality of tubing connections (fluid reservoirs 110, See Fig. 8 and Para. 0090 of Coppeta ; Para. 0041 discusses how the fluid reservoirs are configured to hold a vertical column of fluid) configured to provide for the vertical entry or exit of fluid to and/or from the bioreactor vessel. Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Ingber and the apparatus of Itoh is capable of the recitation of claim 4 . As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Itoh (see MPEP §2114). Furthermore, it should be noted that the fluid reservoirs would be capable of connecting with tubing to enable vertical entry or exit of an applied fluid. With respect to claim 5 the combination of Coppeta and Ingber teaches a plurality of tubing connection that include a first tubing connection formed in one end of the lid and a second tubing connection formed in an opposite end of the lid (See Fig. 8 of Coppeta for depiction of the plurality of plurality of fluid reservoirs 110 spread in array across the entirety of the top surface of the first structural layer 550). With respect to claim 9 the combination of Coppeta and Ingber teaches that the lid includes a plurality of vertically-oriented bolstering supports around a periphery of the lid (See Fig. 8 reproduced below). Fig. 8 (reproduction) With respect to claim 10 the combination of Coppeta and Ingber teaches that the base includes a plurality of strengthening ribs extending generally perpendicularly with respect to a peripheral edge of the base (See Fig. 8 reproduced above). Claim(s) 6-8 is/are reject ed under 35 U.S.C. 103 as being unpatentable over Ingber et al (US 2015/0209783 A1) in view of Hoesl (US 2020/0386197 A1). Refer above for the teachings of Ingber. With respect to claim 6 Ingber fails to teach that the membrane includes a plurality of apertures located along a peripheral edge of the membrane, the plurality of apertures being configured to receive the plurality of heat stakes therethrough to anchor the membrane to the lid and the base . Hoesl teaches a housing assembly (100) that is provided with particulate filtration media 14 configured to remove entrained particulates from the air and an adsorbent material (200) extending about an entire internal circumference of the housing assembly between an inlet (12) and an outlet (16) such that all air passing between the inlet to the outlet must pass through the adsorbent material (See para. 0038). A frame is provided which is configured to contain the adsorbent material, this frame is illustrated particularly in FIGS. 2-10, the frame 300 is then configured to be permanently affixed to an interior of the housing 100, and in some instances between the inlet and the outlet. The placement of the frame and adsorbent material can then be provided in such a manner that any air or gasses escaping from the outlet in a reverse flow condition are configured to come into contact with the adsorbent material 200 contained within the frame 300 such that hydrocarbons contained in the air are adsorbed by the adsorbent material (See Para. 0039). The frame 300 can be provided with a plurality of corresponding apertures 316 provided about a perimeter edge, such as about a flange 314, or about an opposing edge of the first portion and an opposing edge of the second portion (See Para. 0045). These apertures provided on the first and second portions which are lined up provide a means by which the frame 300 can be permanently affixed to the housing 100. As illustrated in FIGS. 4-7, the housing 100 can then include one or more pins or posts 110 which are placed in such a manner and provided with sufficient length so as to extend through at least one of the one or more aligned apertures so as to secure the relative position between the frame 300 and the housing 100. Then a portion of each pin 110 can then be heat staked or otherwise deformed so as to mushroom a distal end of each pin and thus create an associated interfering lip 112 which cannot pass through the apertures or otherwise forms an interference fit with each associated one or more corresponding aperture through which the pin 110 extends (See Para. 0046). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the perimeter-placed apertures of Hoesl as the mechanism of connecting the various layers of the bubble trap of Ingber to create a lip that ensures a fluid-tight seal of the bubble trap (See P ara. 0046 of Hoesl ). With respect to claim 7 the combination of Ingber and Hoesl teaches the inclusion of a gasket (gasket embossments 332,334, See Fig. 3A and Para. 0046 of Ingber) intermediate to the membrane and the lid . With respect to claim 8, the combination of Ingber and Hoesl teaches that the gasket includes a plurality of apertures located along a peripheral edge of the gasket, the plurality of apertures being configured to receive the plurality of heat stakes therethrough to anchor the gasket to the lid and the base (See Paras. 0045-0046 of Hoesl for discussion of the incorporation of apertures to anchor the various layers, including the adsorbent material and filtration media to the frame and housing ; Para. 0046 of Ingber discloses that the gasketing embossments extend around and define the shape of chambers 322 and Para. 0050 discloses that gasketing embossments can be incorporated onto each side of the membrane). Claim(s) 11-13 i s/are rejected under 35 U.S.C. 103 as being unpatentable over Coppeta et al (US 2018/0142196 A1) and Ingber et al (US 2015/0209783 A1) in view of DeSilets et al (US 2002/0189374 A1). Refer above for the combined teachings of Coppeta and Ingber. With respect to claim 11, the combination of Coppeta (Fig. 8) and Ingber fails to teach that the base includes a plurality of wells configured to receive corresponding support posts of a rocking platform of a bioprocessing system. Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. Prior art that would be capable of performing the recited function suffice read upon the claimed subject matter. Additionally, applicant should note that the recited “rocking platform of a bioprocessing system” has not been positively recited as a feature of the currently claimed invention. DeSilets teaches a multi-well test filter plate (10) that is provided with posts (48, 49) which fit, respectively, in holes (46, 47) of multi-well receiver plate (11) when multi-well receiver plate is positioned below the multi-well filter plate (See Para. 0034). Referring to FIGS. 3 and 3a, the posts 48 and 49 fit respectively into holes 46 and 47. Hole 46 is shaped with a three-sided perimeter so that post 48 contacts the walls of the hole 46 at three points 43 a,b and c. This mode of contact prevents multi - well filter plate 10 from moving laterally with respect to the multi - well receiver plate 11. Post 49 contacts the walls of hole 47, in this embodiment shown in the form of a slot, at two points 45a and b so that part to part variations, or misalignment can only be accommodated in the direction shown by arrow 37. The lowermost ends of posts 48 and 49 are beveled to promote ease of insertion of the posts 48and 49 into holes 46 and 47 (See Para. 0035). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the holes of the multi-well receiver plate of DeSilets into the base plate of combined Coppeta and Ingber to ensure a variable contact fit between the various layers of the device, when other layers are fitted with posts (See Paras. 0034-0035 of DeSilets ). With respect to claim 12, applicant has recited a limitation that is dependent upon a limitation that has not been positively recited (support posts). Thus, it should be noted that Para. 0035 of DeSilets teaches that hole 46 is shaped with a three sided perimeter and hole 47 is in the form of a slot. With respect to claim 13, the combination of Coppeta, Ingber, and DeSilets teaches that one of the plurality of wells has an oblong shape (See para. 0035 for discussion of how hole 47 is in the form of a slot). Claim(s) 14 is/are reje cted under 35 U.S.C. 103 as being unpatentable over Coppeta et al (US 2018/0142196 A1) and Ingber et al (US 2015/0209783 A1) in view of John (US 2007/0063389 A1). Refer above for the combined teachings of Coppeta and Ingber. With respect to claim 14 the combination of Coppeta and Ingber fails to teach that a membrane-facing surface of the base has a textured surface. John teaches a n apparatus and a method for the separation of a material layer (4) hardened on a flat plane (2) serving as a reference by means of a flexible, elastic separating layer (1) arranged between plane and material layer and designed in the form of a film or a gel-like material (See abstract). In order to prevent adhesion of the film to the bottom plate and ensuring supply of air , and hence , preventing the film from being sucked against the plane/bottom plate can be transposed by deliberately produced surface roughness or structuring [0042] a) on the lower side of the film (FIG. 5a) by micro/nano-structuring or [0043] b) on the side of the bottom plate oriented towards the film (FIG. 5b), e.g. by slight etching of the glass surface or suitably rough coatings (ITO coating) (See Para. 0041). It would have been obvious to one of ordinary skill in the art before ethe effective filing date of the claimed invention to incorporate the etching of suitably rough coatings taught by John in membrane-facing surface of the base of combined Coppeta and Ingber such that the membrane is prevented from being adhered to the surface of the base (See Para. 0041 of John). Claim(s) 15 is/are rej ected under 35 U.S.C. 103 as being unpatentable over Ingber et al (US 2015/0209783 A1) in view of Coppeta et al (US 2018/0142196 A1). Refer above for the teachings of Ingber. With respect to claim 15 Ingber fails to teach that the membrane is formed from fluorinated ethylene propylene. Coppeta teaches a multi-well cell culture platform (105), wherein a membrane (140) is sandwiched between second and third structural layers, respectively (560 and 570, See Fig. 4A and Para. 0079). The membrane may be a non-permeable membrane. In some implementations, the membrane may be a tensioned membrane. In some implementations, the membrane may be a non-tensioned membrane that includes fluorinated ethylene propylene (FEP) (See Para. 0048). FEP is a gas/oxygen permeable polymer that may allow fluid flow to be decoupled from oxygen requirements or enable s static cell cultures where there is no flow in either microchannel (See Para. 0092). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the membrane of Ingber of FEP, as taught by Coppeta, such that fluid flow may be decoupled from oxygen requirements when static cell cultures are present (See Para. 0092 of Coppeta). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT BRITTANY I FISHER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (469)295-9182 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT IFP . 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, FILLIN "SPE Name?" \* MERGEFORMAT James Lin can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-8902 . 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. /BRITTANY I FISHER/ Examiner, Art Unit 1796 March 24, 2026
Read full office action

Prosecution Timeline

May 25, 2023
Application Filed
Mar 24, 2026
Non-Final Rejection — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
84%
Grant Probability
96%
With Interview (+12.3%)
2y 11m
Median Time to Grant
Low
PTA Risk
Based on 520 resolved cases by this examiner. Grant probability derived from career allow rate.

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